Regulatory

There's been much talk of how US health reform will impact physicians, patients, and insurance companies. But how will it affect the often overlooked specialty drug market?

A timeline of some of the landmark legislation, court decisions, and drug scandals that helped forge the FDA

Health reform requires detailed tracking and full disclosure of fees to docs for marketing and research

FDA seeks to regulate genetic tests more actively, while encouraging diagnostic development

The effectiveness of DTC prescription advertising hinges on a consumer's thirst for information. A new study intimates the less info consumers are given up front, the more they seem willing to learn

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?

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.

Berwick's mission: To successfully translate the new healthcare bill into practice.

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.

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.

FDA's risk-reduction requirements could be the bridge to a bright new future for the pharma industry.

Drug prices, doctor payments, and FDA regulatory decisions are candidates for expanded disclosure.

GSK's blockbuster diabetes drug Avandia was the subject of a number of studies this week offering good and bad news. But the company's big challenge is going to be FDA's advisory review panel set to meet in two short weeks.

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.

FDA and industry seek to ensure drug quality in a world complicated by global outsourcing and theft.

The Orphan Drug Act of 1983 has been a roaring success. So why is everybody trying to mess with it?

Under the new healthcare regime, pharma will ante up fees and rebates in return for expanded sales and safeguards.

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.

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.

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.

FDA Commissioner Margaret Hamburg looks to bolster the agency's scientific expertise.

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.

FDA's new Sentinel System is going live, but the signals may be difficult to assess.

Pharma companies need a clear online policy that addresses employee obligations, monitoring guidelines, and engagement roles.

Obligations to fund and support costly studies can extend beyond the period of market exclusivity, giving generics competitors an advantage.

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.

Added funds for FDA to come from new user fees, largely for food and tobacco regulation.

The popular antidepressant is associated with up to 91 percent increase in risk of death in patients undergoing tamoxifen treatment for breast cancer.

R&D is surging, but new methods and data raise new manufacturing and regulatory challenges.

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.