Regulatory

FDA's opiod REMS implies there is still value in industry-sponsored CME

Successful negotiations require a willingness to take risks and an ability to adapt

To decide on a course of treatment, patients need to be told the truth straight up

Suggestions for testing new ways of addressing difficult issues of risk

A federal appeals court has lifted a ban on federal funding for embryonic stem cell research.

Considering Big Pharma's trade objectives, the success of regional regulatory harmonization is not insignificant

Stiff price tags draw scrutiny from Congress and consumers, and raise questions about FDA policies

Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help

Courts, Congress review policies and programs shaping drug costs and access

FDA's Sentinel Initiative raises broader questions about tapping patient information and health IT for comparative studies in drug development

The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency

Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead

Cegedim survey documents whether European industry is ready for the challenge of new compliance and disclosure risks on promotional spend

November 6, 2010.

Harvard professor Daniel Carpenter offers a piercing analysis of the FDA and sheds light on its biggest challenges

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.