Pharmaceutical Executive - Regulatory
http://www.pharmexec.com/pharmexec/Regulatory/Article/list/43767
New developments and strategies for success in dealing with FDA, OIG, SEC, EMEA, and
more.2013-06-19T13:29:37ZManufacturers Under Pressure to Manage Painkillers
http://www.pharmexec.com/pharmexec/Regulatory/Manufacturers-Under-Pressure-to-Manage-Painkillers/ArticleStandard/Article/detail/812419?contextCategoryId=43767&ref=25
Opioid abuse generates calls for efforts to curb distribution, develop abuse-resistant
formulations.2013-05-06T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/192013/812419nullXMLEuropean Biotech Struggles to Thrive
http://www.pharmexec.com/pharmexec/Europe/European-Biotech-Struggles-to-Thrive/ArticleStandard/Article/detail/812420?contextCategoryId=43767&ref=25
While not as bleak as believed, the outlook of European biotech sector is struggling compared with its
US counterpart.2013-05-06T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/192013/812420/EU_flag_120_thumbnail.gif
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/192013/812420nullXMLIs That VBP on the Horizon, or a Mirage?
http://www.pharmexec.com/pharmexec/Global/Is-That-VBP-on-the-Horizon-or-a-Mirage/ArticleStandard/Article/detail/813746?contextCategoryId=43767&ref=25
Value-based pricing in the United Kingdom is getting closer, but it remains out of
focus.2013-05-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/212013/813746nullXMLObamacare Will Boost Private Managed Care
http://www.pharmexec.com/pharmexec/Regulatory/Obamacare-Will-Boost-Private-Managed-Care/ArticleStandard/Article/detail/813737?contextCategoryId=43767&ref=25
Public access expansion under the ACA isn't really a "government
takeover."2013-05-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/212013/813737/simon-kutcher-figure_thumbnail.jpg
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/212013/813737nullXMLIs National Drug Pricing Freedom in Europe Nearing its Expiry Date?
http://www.pharmexec.com/pharmexec/Global/Is-National-Drug-Pricing-Freedom-in-Europe-Nearing/ArticleStandard/Article/detail/810217?contextCategoryId=43767&ref=25
The European Union's attempt to update its transparency rules sparks new debate.2013-04-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/152013/810217nullXMLWho's Really in Charge of European Drug Registration?
http://www.pharmexec.com/pharmexec/Global/Whos-Really-in-Charge-of-European-Drug-Registratio/ArticleStandard/Article/detail/808528?contextCategoryId=43767&ref=25
European Commision blocks the authorization of a life-saving liver drug outside of
France.2013-03-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/122013/808528nullXMLAnother Round of FDA Legislation?
http://www.pharmexec.com/pharmexec/Washington+Report/Another-Round-of-FDA-Legislation/ArticleStandard/Article/detail/808519?contextCategoryId=43767&ref=25
Pressure for action on key enforcement and regulatory issues may prompt congressional action this
year.2013-03-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/122013/808519nullXMLTurkey: A Promise Restored?
http://www.pharmexec.com/pharmexec/Global/Turkey-A-Promise-Restored/ArticleStandard/Article/detail/805003?contextCategoryId=43767&ref=25
After a decade of strife, the dialogue between industry and government appears to have entered a
positive new phase. Julian Upton reports.2013-02-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/062013/805003/Turkey_120_thumbnail.jpgXMLCompliance in the C-Suite
http://www.pharmexec.com/pharmexec/Regulatory/Compliance-in-the-C-Suite/ArticleStandard/Article/detail/803311?contextCategoryId=43767&ref=25
Compliance officers have risen into management's highest ranks, by choice in some organizations, and
by government decree in others. Either way, their importance as a strategic partner can hardly be
understated.2013-01-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/042013/803311/businessman-_compliance_120_thumbnail.jpg
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/042013/803311nullXMLThe Puzzle Master: EMA's Guido Rasi
http://www.pharmexec.com/pharmexec/Europe/The-Puzzle-Master-EMAs-Guido-Rasi/ArticleStandard/Article/detail/799841?contextCategoryId=43767&ref=25
Europe's chief regulator charts a strategy from many moving parts. Dr Guido Rasi talks to Pharm Exec's
William Looney.2012-12-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/502012/799841/Rasi_flash.jpgXMLGermany's Price Reform Revolution
http://www.pharmexec.com/pharmexec/Regulatory/Germanys-Price-Reform-Revolution/ArticleStandard/Article/detail/799843?contextCategoryId=43767&ref=25
At two years and counting, what's the secret of success in negotiating pricing under the new AMNOG
legislation?2012-12-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/502012/799843nullXMLOTC Crunch Time in California
http://www.pharmexec.com/pharmexec/Regulatory/OTC-Crunch-Time-in-California/ArticleStandard/Article/detail/796506?contextCategoryId=43767&ref=25
Over-the-counter products face a new wave of regulation.2012-11-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/462012/796506nullXMLBudgets, Biosimilars, and Bad Ads
http://www.pharmexec.com/pharmexec/Washington+Report/Budgets-Biosimilars-and-Bad-Ads/ArticleStandard/Article/detail/796505?contextCategoryId=43767&ref=25
While the nation was embroiled in the presidential elections, a number of important legal and
regulatory issues absorbed pharmaceutical executives, writes Jill Wechsler.2012-11-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/462012/796505/senate_small_thumbnail.jpg
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/462012/796505nullXMLRichard Bergström — Europe's Medicine Man
http://www.pharmexec.com/pharmexec/Europe/Richard-Bergstroumlm-mdash-Europes-Medicine-Man/ArticleStandard/Article/detail/791511?contextCategoryId=43767&ref=25
The new head of EFPIA faces a Promethean challenge: selling the merits of costly science and
innovation in an era of bristling competition, fiscal crisis, and declining demographics.2012-10-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/402012/791511/bergstrom_120_thumbnail.jpgXMLPatients Wade Into the Pricing Debate
http://www.pharmexec.com/pharmexec/Global/Patients-Wade-Into-the-Pricing-Debate/ArticleStandard/Article/detail/788396?contextCategoryId=43767&ref=25
Europe's fiscal crisis is becoming a new rallying cry for patient groups—but regional
unity is still elusive.2012-09-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/372012/788396nullXMLThe Endless Treadmill of End-of-Life Care
http://www.pharmexec.com/pharmexec/Regulatory/The-Endless-Treadmill-of-End-of-Life-Care/ArticleStandard/Article/detail/788393?contextCategoryId=43767&ref=25
Bending the cost curve back to valuing the cycle of life.2012-09-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/372012/788393nullXMLCosts, Coverage, and Court Decisions
http://www.pharmexec.com/pharmexec/Washington+Report/Costs-Coverage-and-Court-Decisions/ArticleStandard/Article/detail/788389?contextCategoryId=43767&ref=25
Its election season and drug pricing issues are once again front and center in the policy wars on
managing the high cost of healthcare.2012-09-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/372012/788389/senate_small_thumbnail.jpg
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/372012/788389nullXMLCompliance Kulture: The Facts Behind GSK's CIA
http://www.pharmexec.com/pharmexec/Regulatory/Compliance-Kulture-The-Facts-Behind-GSKs-CIA/ArticleStandard/Article/detail/784891?contextCategoryId=43767&ref=25
Big Pharma talks a lot about changing its business model to one that prioritizes quality and value
over quantity and waste. While the healthcare "ecosystem" waits for pharma to grow into this model,
government is delivering a comeuppance that actually puts it in the driver's seat and gaining the upper
hand.2012-08-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/322012/784891nullXMLWho Will Pay for New Drugs?
http://www.pharmexec.com/pharmexec/Washington+Report/Who-Will-Pay-for-New-Drugs/ArticleStandard/Article/detail/780615?contextCategoryId=43767&ref=25
Comparative research documenting value and affordability is key to obtaining coverage for high-cost
therapies. Jill Wechsler reports.2012-07-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/272012/780615/Jill_Wechsler_129_thumbnail.jpg
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/272012/780615nullXMLEurope Responds to Medical Device 'Crisis'
http://www.pharmexec.com/pharmexec/Regulatory/Europe-Responds-to-Medical-Device-Crisis/ArticleStandard/Article/detail/777877?contextCategoryId=43767&ref=25
A recent medical device controversy in France has pushed European health ministers to agree on a
crisis management program for the troubled sector.2012-06-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/242012/777877nullXMLComparative Effectiveness Research: Challenges for Pharma
http://www.pharmexec.com/pharmexec/Top+Feature/Comparative-Effectiveness-Research-Challenges-for-/ArticleStandard/Article/detail/772674?contextCategoryId=43767&ref=25
Switching Rx drugs to OTC and adding comparative data could broaden access to treatment, writes Jill
Wechsler.2012-05-09T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/192012/772674/hurdle_176_flash.jpgHTMLGovernment: Big Pharma's Best Friend in Emerging Markets?
http://www.pharmexec.com/pharmexec/Regulatory/Government-Big-Pharmas-Best-Friend-in-Emerging-Mar/ArticleStandard/Article/detail/773570?contextCategoryId=43767&ref=25
To gain market access in emerging markets, pharma companies face pressure to offer a convincing
Corporate Value Proposition to governments.2012-05-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/202012/773570nullXMLProviding Access Now
http://www.pharmexec.com/pharmexec/Regulatory/Providing-Access-Now/ArticleStandard/Article/detail/767909?contextCategoryId=43767&ref=25
While regulatory frameworks and medical practices differ between countries, many patients still need
early access to new drugs. Industry can help.2012-04-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/142012/767909/access_traffic-light_120_thumbnail.jpg
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/142012/767909nullXMLHow Can We Fix the FDA?
http://www.pharmexec.com/pharmexec/Regulatory/How-Can-We-Fix-the-FDA/ArticleStandard/Article/detail/764162?contextCategoryId=43767&ref=25
How can we better balance addressing medical needs with ensuring that new drugs are safe and
effective? Ron Cohen reports.2012-03-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/102012/764162/ron_cohen_120_thumbnail.jpgXMLWhen Talk is Not So Cheap
http://www.pharmexec.com/pharmexec/Washington+Report/When-Talk-is-Not-So-Cheap/ArticleStandard/Article/detail/764166?contextCategoryId=43767&ref=25
FDA and industry are pushing user fees, while they struggle with curbs on
communications.2012-03-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/102012/764166nullXMLFDA Unveils Guidance for Biosimilar Development
http://www.pharmexec.com/pharmexec/Noteworthy/FDA-Unveils-Guidance-for-Biosimilar-Development/ArticleStandard/Article/detail/758411?contextCategoryId=43767&ref=25
After months of anticipation, FDA finally issued guidances last month that outlines its
recommendations for developing and approving biosimilar therapies.2012-02-10T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/062012/758411/fda.jpg_thumbnail.jpg
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/062012/758411nullHTMLAs the Compliance Net Tightens...
http://www.pharmexec.com/pharmexec/Regulatory/As-the-Compliance-Net-Tightens/ArticleStandard/Article/detail/757955?contextCategoryId=43767&ref=25
Time to stop and think about CMS's 'Proposed Rule' on transparency and what it means for the life
sciences business model.2012-02-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/062012/757955/signs_caution_120_thumbnail.jpg
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/062012/757955nullXMLCosts and Benefits of Health Reform
http://www.pharmexec.com/pharmexec/Washington+Report/Costs-and-Benefits-of-Health-Reform/ArticleStandard/Article/detail/757960?contextCategoryId=43767&ref=25
Will expanded markets and ACOs offset higher rebates, added fees, and closer scrutiny of marketing and
prices?2012-02-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/062012/757960nullXMLFDA Social Media Guidelines: Irresponsible?
http://www.pharmexec.com/pharmexec/Back+Page/FDA-Social-Media-Guidelines-Irresponsible/ArticleStandard/Article/detail/757971?contextCategoryId=43767&ref=25
After two years of waiting, FDA issued the first in a series of planned guidelines on social media at
the end of last year. We look at some of the experts' reactions.2012-02-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/062012/757971/Social_media.120_thumbnail.jpgXMLNew Year, New Issues
http://www.pharmexec.com/pharmexec/Washington+Report/New-Year-New-Issues/ArticleStandard/Article/detail/755092?contextCategoryId=43767&ref=25
Look for action in 2012 on drug access, shortages, innovation, and transparency.2012-01-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/012012/755092nullXMLEssential Questions for Essential Benefits
http://www.pharmexec.com/pharmexec/Regulatory/Essential-Questions-for-Essential-Benefits/ArticleStandard/Article/detail/755093?contextCategoryId=43767&ref=25
A key consideration under the Affordable Care Act is how states select plans for drug
coverage.2012-01-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/012012/755093nullXMLThe Payoff for Payers
http://www.pharmexec.com/pharmexec/Strategy/The-Payoff-for-Payers/ArticleStandard/Article/detail/752333?contextCategoryId=43767&ref=25
Thorough risk assessment is essential before placing bets on good evidence that clears a path to
approval.2011-12-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/512011/752333nullXMLSpotlight on OTCs
http://www.pharmexec.com/pharmexec/Regulatory/Spotlight-on-OTCs/ArticleStandard/Article/detail/747591?contextCategoryId=43767&ref=25
With OTCs challenging traditional approaches to quality, new opportunities are arising to support
industry innovation and advance public health.2011-11-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/452011/747591nullXMLThe Drug Shortages Struggle
http://www.pharmexec.com/pharmexec/Washington+Report/The-Drug-Shortages-Struggle/ArticleStandard/Article/detail/747603?contextCategoryId=43767&ref=25
Clamor for critical therapies prompts probes of prices, production practices.2011-11-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/452011/747603nullXMLJanet Woodcock: At the Helm of Industry
http://www.pharmexec.com/pharmexec/Regulatory/Janet-Woodcock-At-the-Helm-of-Industry/ArticleStandard/Article/detail/744328?contextCategoryId=43767&ref=25
Janet Woodcock, MD, Director, FDA Center for Drug Evaluation and Research2011-10-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/422011/744328nullXMLSir Michael Rawlins: Regulation and Reputation
http://www.pharmexec.com/pharmexec/Europe/Sir-Michael-Rawlins-Regulation-and-Reputation/ArticleStandard/Article/detail/744315?contextCategoryId=43767&ref=25
Sir Michael Rawlins, Chairman of the UK National Institute for Health and Clinical
Excellence2011-10-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/422011/744315nullXMLRebates and Reform
http://www.pharmexec.com/pharmexec/Washington+Report/Rebates-and-Reform/ArticleStandard/Article/detail/739262?contextCategoryId=43767&ref=25
User-fee renewal legislation sets the stage for new policies affecting reimbursement, research, and
regulatory oversight.2011-09-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/372011/739262nullXMLCongressional Investigations: What Every Exec Should Know
http://www.pharmexec.com/pharmexec/Noteworthy/Congressional-Investigations-What-Every-Exec-Shoul/ArticleStandard/Article/detail/734678?contextCategoryId=43767&ref=25
When faced with legislative scrutiny, be prepared, be truthful, and don't be afraid to say 'I don't
know'...2011-08-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/322011/734678/grand_jury_thumbnail.jpg
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/322011/734678nullXMLThe Supremes Shape Pharma
http://www.pharmexec.com/pharmexec/Washington+Report/The-Supremes-Shape-Pharma/ArticleStandard/Article/detail/734671?contextCategoryId=43767&ref=25
A number of important decisions from the Supreme Court will affect drug marketing, research, and
regulation2011-08-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/322011/734671nullXMLMind the Gap!
http://www.pharmexec.com/pharmexec/Back+Page/Mind-the-Gap/ArticleStandard/Article/detail/734672?contextCategoryId=43767&ref=25
No one doubts the importance of health expenditures ? but then, euros, like dollars, don't grow on
trees2011-08-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/322011/734672nullXMLEurope in HTA Gridlock
http://www.pharmexec.com/pharmexec/Global/Europe-in-HTA-Gridlock/ArticleStandard/Article/detail/734673?contextCategoryId=43767&ref=25
HTAs are gridlocked by diverse national requirements, a lack of alignment on processes, and even on
the value of their outcomes.2011-08-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/322011/734673nullXMLBattles over Biosimilars
http://www.pharmexec.com/pharmexec/Washington+Report/Battles-over-Biosimilars/ArticleStandard/Article/detail/730199?contextCategoryId=43767&ref=25
Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars
game2011-07-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/282011/730199nullXMLOptimizing your Value with Payers
http://www.pharmexec.com/pharmexec/Partnerships/Optimizing-your-Value-with-Payers/ArticleStandard/Article/detail/726108?contextCategoryId=43767&ref=25
Successful negotiations require a willingness to take risks and an ability to adapt2011-06-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/242011/726108nullXMLEducating Physicians
http://www.pharmexec.com/pharmexec/Washington+Report/Educating-Physicians/ArticleStandard/Article/detail/726080?contextCategoryId=43767&ref=25
FDA's opiod REMS implies there is still value in industry-sponsored CME2011-06-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/242011/726080nullXMLHow to Be More Truthful
http://www.pharmexec.com/pharmexec/Noteworthy/How-to-Be-More-Truthful/ArticleStandard/Article/detail/726096?contextCategoryId=43767&ref=25
Suggestions for testing new ways of addressing difficult issues of risk2011-06-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/242011/726096nullXMLFederal Appeals Court Lifts Ban on Funding for Embryonic Stem Cell Research
http://www.pharmexec.com/pharmexec/Regulatory/Federal-Appeals-Court-Lifts-Ban-on-Funding-for-Emb/ArticleStandard/Article/detail/722099?contextCategoryId=43767&ref=25
A federal appeals court has lifted a ban on federal funding for embryonic stem cell
research.2011-05-05T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/202011/722099nullHTMLThe Elusive Single-Point-of-Entry
http://www.pharmexec.com/pharmexec/Regulatory/The-Elusive-Single-Point-of-Entry/ArticleStandard/Article/detail/719593?contextCategoryId=43767&ref=25
Considering Big Pharma's trade objectives, the success of regional regulatory harmonization is not
insignificant2011-05-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/192011/719593nullXMLOutrage Over Drug Prices
http://www.pharmexec.com/pharmexec/Washington+Report/Outrage-Over-Drug-Prices/ArticleStandard/Article/detail/719622?contextCategoryId=43767&ref=25
Stiff price tags draw scrutiny from Congress and consumers, and raise questions about FDA
policies2011-05-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/192011/719622nullXMLHow US Health Reform Is Hitting Canada
http://www.pharmexec.com/pharmexec/Medical+Education/How-US-Health-Reform-Is-Hitting-Canada/ArticleStandard/Article/detail/716288?contextCategoryId=43767&ref=25
Canada's Russell Williams, of Rx&D, talks about the impact of US health reform on his role
as chief spokesman for the country's R&D industry2011-04-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/162011/716288/Russell_Williams_2009_High__thumbnail.jpg
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/162011/716288nullXMLChallenges, Changes, Commitments
http://www.pharmexec.com/pharmexec/Washington+Report/Challenges-Changes-Commitments/ArticleStandard/Article/detail/707514?contextCategoryId=43767&ref=25
The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and
leadership revisions to the agency2011-02-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/072011/707514nullXMLPolitics & PDUFA
http://www.pharmexec.com/pharmexec/Washington+Report/Politics-amp-PDUFA/ArticleStandard/Article/detail/703038?contextCategoryId=43767&ref=25
Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors
in the year ahead2011-01-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/032011/703038nullXMLIs Euroland Following the US Disclosure Lead?
http://www.pharmexec.com/pharmexec/Noteworthy/Is-Euroland-Following-the-US-Disclosure-Lead/ArticleStandard/Article/detail/700434?contextCategoryId=43767&ref=25
Cegedim survey documents whether European industry is ready for the challenge of new compliance and
disclosure risks on promotional spend2010-12-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/512010/700434nullXMLNew Ballgame in Washington
http://www.pharmexec.com/pharmexec/Washington+Report/New-Ballgame-in-Washington/ArticleStandard/Article/detail/700430?contextCategoryId=43767&ref=25
Republican gains in Congress create uncertainty for health reform, drug regulation, and biomedical
research2010-12-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/512010/700430nullXMLScience and Politics at the FDA
http://www.pharmexec.com/pharmexec/Noteworthy/Science-and-Politics-at-the-FDA/ArticleStandard/Article/detail/695701?contextCategoryId=43767&ref=25
Harvard professor Daniel Carpenter offers a piercing analysis of the FDA and sheds light on its
biggest challenges2010-11-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/472010/695701/Science-and-Politics-at-the-FDA_thumbnail.jpg
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/472010/695701nullXMLHow the FDA Grew
http://www.pharmexec.com/pharmexec/Noteworthy/How-the-FDA-Grew/ArticleStandard/Article/detail/695706?contextCategoryId=43767&ref=25
A timeline of some of the landmark legislation, court decisions, and drug scandals that helped forge
the FDA2010-11-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/472010/695706/Tree_thumbnail.jpg
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/472010/695706nullXMLActos Deemed as Safe as Avandia
http://www.pharmexec.com/pharmexec/Regulatory/Actos-Deemed-as-Safe-as-Avandia/ArticleStandard/Article/detail/684476?contextCategoryId=43767&ref=25
Results from a new study reveal that patients taking Takeda's diabetes treatment Actos have the same
rate and kind of side effects as GSK's embattled Avandia. Is this a good sign?2010-08-25T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/352010/684476nullHTMLNicOx Shutters HQ After Approval Fail
http://www.pharmexec.com/pharmexec/News+Analysis/NicOx-Shutters-HQ-After-Approval-Fail/ArticleStandard/Article/detail/681789?contextCategoryId=43767&ref=25
In the wake of FDA's refusal to approve the lead drug in NicOx's pipeline, the French firm has decided
to close its US headquarters.2010-08-04T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/322010/681789nullHTMLFDA to Weigh In on Obesity Drug
http://www.pharmexec.com/pharmexec/Regulatory/FDA-to-Weigh-In-on-Obesity-Drug/ArticleStandard/Article/detail/678935?contextCategoryId=43767&ref=25
Vivus's weight-loss drug Qnexa is heading into an FDA review with the backing of generally positive
study data. Will FDA give the thumbs up? Depends on how severe it thinks the side effects are.2010-07-14T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/292010/678935nullHTMLBerwick Appointed Head of CMS
http://www.pharmexec.com/pharmexec/News+Analysis/Berwick-Appointed-Head-of-CMS/ArticleStandard/Article/detail/678274?contextCategoryId=43767&ref=25
With a long, hard fight looming, President Obama decided to go around Congress to install Don Berwick,
founder of the Institute for Healthcare Improvement, as the top administrator of the Centers for Medicaid and
Medicare Services.2010-07-08T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/282010/678274nullHTMLRoad Map for REMS
http://www.pharmexec.com/pharmexec/Regulatory/Road-Map-for-REMS/ArticleStandard/Article/detail/678715?contextCategoryId=43767&ref=25
FDA's risk-reduction requirements could be the bridge to a bright new future for the pharma
industry.2010-07-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/292010/678715/resized_thumbnail.jpg
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/292010/678715nullXMLFDA Prepares to Walk the Opiate REMS Line
http://www.pharmexec.com/pharmexec/News+Analysis/FDA-Prepares-to-Walk-the-Opiate-REMS-Line/ArticleStandard/Article/detail/676972?contextCategoryId=43767&ref=25
FDA's meeting on the adoption of REMS for certain prescription opioids doesn't begin until July 22,
but the agency's proposal released Tuesday portends a meeting fraught with conflict over the balance between
curbing abuse and protecting patient access.2010-06-30T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/272010/676972nullHTMLSunshine Laws Stump Compliance Departments
http://www.pharmexec.com/pharmexec/Regulatory/Sunshine-Laws-Stump-Compliance-Departments/ArticleStandard/Article/detail/667301?contextCategoryId=43767&ref=25
A new Cegedim Dendrite study shows just how ill-equipped pharmaceutical companies are to deal with
spending disclosure legislation, and how many are turning to third parties to do the job.2010-04-28T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/182010/667301nullHTMLDiscussions About Drug User-Fees
http://www.pharmexec.com/pharmexec/News+Analysis/Discussions-About-Drug-User-Fees/ArticleStandard/Article/detail/665248?contextCategoryId=43767&ref=25
The Prescription Drug User Fee Act will expire in 2012 and FDA is working hard to renegotiate the act
before that end date. The contenders: in one corner, the pharma industry; in the other, the general public and
consumers - and just about everyone has an opinion about what needs to be changed.2010-04-14T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/162010/665248nullHTMLControlled-Release OxyContin Approved as Rx ODs Spike
http://www.pharmexec.com/pharmexec/Regulatory/Controlled-Release-OxyContin-Approved-as-Rx-ODs-Sp/ArticleStandard/Article/detail/664390?contextCategoryId=43767&ref=25
FDA approves a new formulation of Purdue Pharma's notoriously addictive opioid. This version is
supposed to make it harder for the drug to be repurposed for nefarious consumption.2010-04-07T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/152010/664390nullHTMLFDA Gives Red Light to Ranbaxy for Generic Flomax
http://www.pharmexec.com/pharmexec/News+Analysis/FDA-Gives-Red-Light-to-Ranbaxy-for-Generic-Flomax/ArticleStandard/Article/detail/659857?contextCategoryId=43767&ref=25
The Indian generic firm Ranbaxy was dealt another blow this week as its version of the enlarged
prostate drug Flomax was denied approval in the US just as it was about to go to market.2010-03-03T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/102010/659857nullHTMLManaging REMS for the Long Term
http://www.pharmexec.com/pharmexec/Regulatory/Managing-REMS-for-the-Long-Term/ArticleStandard/Article/detail/661647?contextCategoryId=43767&ref=25
Obligations to fund and support costly studies can extend beyond the period of market exclusivity,
giving generics competitors an advantage.2010-03-01T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/122010/661647nullXMLAvandia 2: Ethical Boogaloo?
http://www.pharmexec.com/pharmexec/News+Analysis/Avandia-2-Ethical-Boogaloo/ArticleStandard/Article/detail/658599?contextCategoryId=43767&ref=25
GSK is coming under serious fire again from the FDA and Senate, who say the company resorted to
scientific flimflammery to keep researchers quiet about Avandia's safety risks.2010-02-24T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/092010/658599nullHTMLStudy Links Paxil to Breast Cancer Patient Deaths
http://www.pharmexec.com/pharmexec/News+Analysis/Study-Links-Paxil-to-Breast-Cancer-Patient-Deaths/ArticleStandard/Article/detail/656474?contextCategoryId=43767&ref=25
The popular antidepressant is associated with up to 91 percent increase in risk of death in patients
undergoing tamoxifen treatment for breast cancer.2010-02-10T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/072010/656474nullHTMLNo Real New Money for Drug Regulation
http://www.pharmexec.com/pharmexec/News+Analysis/No-Real-New-Money-for-Drug-Regulation/ArticleStandard/Article/detail/656473?contextCategoryId=43767&ref=25
Added funds for FDA to come from new user fees, largely for food and tobacco regulation.2010-02-10T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/072010/656473nullHTMLGAO Seeks Price Spike Explanation
http://www.pharmexec.com/pharmexec/Regulatory/GAO-Seeks-Price-Spike-Explanation/ArticleStandard/Article/detail/651795?contextCategoryId=43767&ref=25
At time when people can't even get a 3 percent cost-of-living increase, how can pharma justify price
hikes pushing 500 percent (in some categories). A new study by the government's General Accountability Office
examines why drug products took a massive price leap in recent years.2010-01-13T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/032010/651795nullHTMLFDA Basics Brings the Agency Out of the Closet
http://www.pharmexec.com/pharmexec/Regulatory/FDA-Basics-Brings-the-Agency-Out-of-the-Closet/ArticleStandard/Article/detail/651794?contextCategoryId=43767&ref=25
The push for government transparency continues with Phase I of FDA's plan to expose the inner workings
of that secretive cabal known as the Food and Drug Association. First up, fancy new FAQs.2010-01-13T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/032010/651794nullHTMLChange Agent
http://www.pharmexec.com/pharmexec/Regulatory/Change-Agent/ArticleStandard/Article/detail/648653?contextCategoryId=43767&ref=25
FDA Commissioner Margaret Hamburg has a history of health advocacy and a clear mandate to transform
the agency. But can she succeed where others have failed?2010-01-06T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/512009/648653/i1_thumbnail.jpg
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/512009/648653nullXMLSanofi Gets a Bad Batch of H1N1 Vaccines
http://www.pharmexec.com/pharmexec/Regulatory/Sanofi-Gets-a-Bad-Batch-of-H1N1-Vaccines/ArticleStandard/Article/detail/648743?contextCategoryId=43767&ref=25
Sanofi-Aventis is recalling hundreds of thousands of doses of the childrens' version of its H1N1
vaccine. Conspiracy theorists are going to have a field day.2009-12-16T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/512009/648743nullHTMLFeds Team with Drugmakers to Curb Opioid Misuse
http://www.pharmexec.com/pharmexec/News+Analysis/Feds-Team-with-Drugmakers-to-Curb-Opioid-Misuse/ArticleStandard/Article/detail/647504?contextCategoryId=43767&ref=25
Painkiller abuse has become so prevalent that FDA is working with pharma to create a strategy for
handling misuse of all drugs across the entire opioid category.2009-12-09T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/502009/647504nullHTMLPharma Comes Under Fire for Jump in Rx Prices
http://www.pharmexec.com/pharmexec/News+Analysis/Pharma-Comes-Under-Fire-for-Jump-in-Rx-Prices/ArticleStandard/Article/detail/647503?contextCategoryId=43767&ref=25
Drug manufacturers came under fire at a hearing of the House Energy and Commerce?s health subcommittee
for bumping drug prices 10 percent this year. Pharma claims rumors that it?s boosting costs in anticipation of
healthcare reform are baseless, but the industry could be facing an uphill battle.2009-12-09T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/502009/647503nullHTMLCongress Ups the Pharma Ante for Health Reform
http://www.pharmexec.com/pharmexec/News+Analysis/Congress-Ups-the-Pharma-Ante-for-Health-Reform/ArticleStandard/Article/detail/643863?contextCategoryId=43767&ref=25
House bill boosts rebates and opens the door to government price negotiations.2009-11-24T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/482009/643863nullHTMLGAO Accuses FDA of Tardy Trial Data
http://www.pharmexec.com/pharmexec/News+Analysis/GAO-Accuses-FDA-of-Tardy-Trial-Data/ArticleStandard/Article/detail/637272?contextCategoryId=43767&ref=25
The US oversight arm scripted a hefty report complaining that FDA is not moving fast enough when it
comes to screening clinical trials data for drugs green lit through its expedited approval program.2009-10-28T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/442009/637272nullHTMLNew NIH Leader Backs Personalized Medicine
http://www.pharmexec.com/pharmexec/Regulatory/New-NIH-Leader-Backs-Personalized-Medicine/ArticleStandard/Article/detail/613034?contextCategoryId=43767&ref=25
Collins seeks to parlay genomic discoveries into new biomedical therapies. Comparative effectiveness
research, he says, should identify subpopulation responses to treatment and support personalized
medicine.2009-07-22T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/302009/613034nullREMOTEFDA Boosts Warnings on Propoxyphene Pain Meds
http://www.pharmexec.com/pharmexec/News+Analysis/FDA-Boosts-Warnings-on-Propoxyphene-Pain-Meds/ArticleStandard/Article/detail/609623?contextCategoryId=43767&ref=25
Pain medications containing propoxyphene could lead to overdose and death, according to new labeling
mandated by FDA. However, public requests to take these drugs (including Darvon and Darvocet) off the market have
been denied.2009-07-08T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/282009/609623nullHTMLAre we moving towards global patenting?
http://www.pharmexec.com/pharmexec/Regulatory/Are-we-moving-towards-global-patenting/ArticleStandard/Article/detail/606930?contextCategoryId=43767&ref=25
Patents are an important tool for protecting innovative products, uses or processes intended for
commercialization. A granted patent provides a limited monopoly, normally for up to 20 years from the filing date
of a patent application, giving a patent owner the right to prevent other parties from making, stocking, selling,
using or importing the patented invention without the patent owner's permission. A theoretical ideal for an
innovator would be to obtain a patent in all countries of the world. However, patents must be sought and enforced
in each territory where protection is desired because a global patent does not (yet) exist. For cost reasons, a
decision is usually made as to where to file and process patent applications.2009-07-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/262009/606930nullXMLSudden Deaths and ADHD Meds Not Necessarily Related
http://www.pharmexec.com/pharmexec/News+Analysis/Sudden-Deaths-and-ADHD-Meds-Not-Necessarily-Relate/ArticleStandard/Article/detail/604388?contextCategoryId=43767&ref=25
Feds claim results of study comparing car crash deaths and children on ADHD drugs were not paramount
to pulling kids off of ADHD treatments.2009-06-17T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/252009/604388nullHTMLWHO Pushes H1N1 Flu to Pandemic State
http://www.pharmexec.com/pharmexec/News+Analysis/WHO-Pushes-H1N1-Flu-to-Pandemic-State/ArticleStandard/Article/detail/603039?contextCategoryId=43767&ref=25
The Word Health Organization just bumped the H1N1 influenza to pandemic alert phase 6 (the highest
alert level), making it the first worldwide pandemic in 41 years.2009-06-11T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/242009/603039nullREMOTEFDA Launches Transparency Task Force
http://www.pharmexec.com/pharmexec/News+Analysis/FDA-Launches-Transparency-Task-Force/ArticleStandard/Article/detail/601468?contextCategoryId=43767&ref=25
The feds green lit a task force charged with easing the flow of communication between FDA, pharma
companies, and the general public. While the team is being billed as a task force for transparency, it?s still
unclear what is being revealed.2009-06-03T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/232009/601468nullHTMLFDA Releases Guidance on Risk in Ads
http://www.pharmexec.com/pharmexec/Regulatory/FDA-Releases-Guidance-on-Risk-in-Ads/ArticleStandard/Article/detail/600089?contextCategoryId=43767&ref=25
You know those loud soundtracks and distracting visuals during the safety information in your TV ads?
Critics have been complaining about them, and new draft guidance from FDA is calling them a
"no-no."2009-05-27T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/222009/600089nullHTMLPharma Companies Hit With Warnings for Search Marketing
http://www.pharmexec.com/pharmexec/News+Analysis/Pharma-Companies-Hit-With-Warnings-for-Search-Mark/ArticleStandard/Article/detail/592363?contextCategoryId=43767&ref=25
FDA is cracking down on content in search engine advertisements. The argument is that there is a
serious deficiency of risk information in the tiny link ads that appear on search ads. With pharma already wary of
marketing online, will FDA’s tactic hurt future Web campaigns?2009-04-08T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/152009/592363nullHTMLFDA Demands Pharma Firms Pull Unapproved Drugs
http://www.pharmexec.com/pharmexec/News+Analysis/FDA-Demands-Pharma-Firms-Pull-Unapproved-Drugs/ArticleStandard/Article/detail/590830?contextCategoryId=43767&ref=25
The Feds are on the warpath, cracking down on pharmaceutical companies that manufacture and market
unapproved prescription narcotics.2009-04-01T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/142009/590830nullHTMLComparative Effectiveness Research: Coming Soon?
http://www.pharmexec.com/pharmexec/Regulatory/Comparative-Effectiveness-Research-Coming-Soon/ArticleStandard/Article/detail/589172?contextCategoryId=43767&ref=25
Only time will reveal CER's true definition, and determine the full effects of a CER-based
system2009-03-24T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/132009/589172nullHTMLMassachusetts Passes New Sales and Marketing Rules
http://www.pharmexec.com/pharmexec/News+Analysis/Massachusetts-Passes-New-Sales-and-Marketing-Rules/ArticleStandard/Article/detail/587894?contextCategoryId=43767&ref=25
The latest state-level attempt to regulate pharma marketing is also the most stringent, requiring both
drug and device manufacturers to track and disclose marketing spend. And the state's very important biotech
industry is crying foul.2009-03-18T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/122009/587894nullHTMLGSK Garners FDA Warning Letter for Extraterrestrial Ad Campaign
http://www.pharmexec.com/pharmexec/Marketing/GSK-Garners-FDA-Warning-Letter-for-Extraterrestria/ArticleStandard/Article/detail/584711?contextCategoryId=43767&ref=25
GlaxoSmithKline received a warning letter for use of misleading imagery in its television ad for
Avodart. The Feds felt that comparing prostate size to planets might not be a good idea.2009-03-04T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/102009/584711nullHTMLWyeth Loses Preemption Battle
http://www.pharmexec.com/pharmexec/Regulatory/Wyeth-Loses-Preemption-Battle/ArticleStandard/Article/detail/584710?contextCategoryId=43767&ref=25
The Supreme Court ruled in favor of the plaintiff in a case that has had the pharmaceutical industry
on pins and needles. The verdict hammered home the fact that even though FDA approves a drug, pharmaceutical
companies are responsible for making labels as clear as possible.2009-03-04T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/102009/584710nullHTMLEMEA/Canada Health Suspend Raptiva Sales
http://www.pharmexec.com/pharmexec/News+Analysis/EMEACanada-Health-Suspend-Raptiva-Sales/ArticleStandard/Article/detail/583392?contextCategoryId=43767&ref=25
After more reports surface that link Raptiva to a deadly brain infection, world drug regulation
agencies decide the risks outweigh benefits.2009-02-25T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/092009/583392nullHTMLLilly Gets Green Light to Sell Prasugrel in Europe
http://www.pharmexec.com/pharmexec/News+Analysis/Lilly-Gets-Green-Light-to-Sell-Prasugrel-in-Europe/ArticleStandard/Article/detail/583390?contextCategoryId=43767&ref=25
Lilly's blood thinner earns approval in Europe and challenges Plavix's status as king of the ACS
market.2009-02-25T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/092009/583390nullHTMLBayer to Run Corrective Ad for Birth-Control Pill
http://www.pharmexec.com/pharmexec/News+Analysis/Bayer-to-Run-Corrective-Ad-for-Birth-Control-Pill/ArticleStandard/Article/detail/582362?contextCategoryId=43767&ref=25
FDA reprimanded Bayer for running misleading advertising touting unproven benefits of the
contraceptive Yaz. Now the drug company will shell out $20 million for new ads setting the record
straight.2009-02-18T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/082009/582362nullHTMLFDA Wants More Gardasil Data
http://www.pharmexec.com/pharmexec/News+Analysis/FDA-Wants-More-Gardasil-Data/ArticleStandard/Article/detail/575381?contextCategoryId=43767&ref=25
One week after submitting data to get Gardasil approved for men, Merck gets a total response letter
from FDA requesting additional data before it makes a decision on authorizing the drug for older
women.2009-01-14T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/032009/575381nullHTMLEU Probes Pharma
http://www.pharmexec.com/pharmexec/Regulatory/EU-Probes-Pharma/ArticleStandard/Article/detail/569071?contextCategoryId=43767&ref=25
Last January, the EU raided pharma companies searching for evidence of anti-trust violations. The
newly issued report on the incident comes down hard on industry for what look like normal patent-protection
activities. Could the same thing happen in the US?2008-12-03T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/492008/569071nullHTMLOTC Viagra Not Ready For Prime Time
http://www.pharmexec.com/pharmexec/News+Analysis/OTC-Viagra-Not-Ready-For-Prime-Time/ArticleStandard/Article/detail/568239?contextCategoryId=43767&ref=25
Pfizer decided to pull back its application for an over-the-counter version of its blockbuster ED drug
after the release of a report stating that the ease of availability could lead to misuse of the drug.2008-11-26T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/482008/568239nullHTMLFeds in Hot Water for No-Bid PR Contract
http://www.pharmexec.com/pharmexec/News+Analysis/Feds-in-Hot-Water-for-No-Bid-PR-Contract/ArticleStandard/Article/detail/566823?contextCategoryId=43767&ref=25
Things heat up in Washington as FDA is called to task for a controversial contracts deal with a local
public relations firm. Both the Senate and the House are looking for answers, and the feds no longer have a PR firm
to run damage control.2008-11-19T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/472008/566823nullHTMLFDA Pulls Amgen Brochure for Misleading Language
http://www.pharmexec.com/pharmexec/Regulatory/FDA-Pulls-Amgen-Brochure-for-Misleading-Language/ArticleStandard/Article/detail/563054?contextCategoryId=43767&ref=25
Colorful and cheerful aren’t always a good thing; an illustrated brochure for
Amgen’s Sensipar gets canned by FDA for too thin a listing of side effects and adverse reaction
data.2008-11-05T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/452008/563054nullHTMLWyeth v. Levine Takes Center Stage
http://www.pharmexec.com/pharmexec/Regulatory+News/iWyeth-v-Levinei-Takes-Center-Stage/ArticleStandard/Article/detail/563064?contextCategoryId=43767&ref=25
Wyeth v. Levine was argued before the US Supreme Court on Monday. With the justices asking aggressive
questions of both sides, the verdict remains very much in doubt. All eyes are on Washington.2008-11-05T05:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/452008/563064nullHTMLChantix, Heparin Top List of Adverse Events
http://www.pharmexec.com/pharmexec/Regulatory/Chantix-Heparin-Top-List-of-Adverse-Events/ArticleStandard/Article/detail/561584?contextCategoryId=43767&ref=25
A new study finds that side-effect reports are on the rise, with Chantix and heparin topping the list.
Are popular drugs getting a bad rap because they're in the headlines? Or are people just reporting more side
effects?2008-10-29T04:00:00Z
http://www.pharmexec.com/pharmexec/data/articlestandard/pharmexec/442008/561584nullHTML