Regulatory

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

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

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.

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.

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.

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.