The FDA approved the drug maker's depression drug Brintellix, one day after the Danish company announced a reorg that includes shifting 180 to 200 jobs.
The midnight shutdown put 800,000 government employees on leave, including those at the FDA, NIH and CDC.
A study of government drug review advisory panels suggests that those with members who have financial ties to the drug industry recommended expansion of labeled disease indications for the drugs examined
FDA stakeholders in industry and academia told the agency in August that they're concerned about its newest initiative to make clinical trial data more publicly available
A study of prescription drug direct-to-consumer advertising suggests that it may promote over-diagnosis of high cholesterol and over-treatment for populations where risks of statin use may outweigh potential benefits.
The Federal Trade Commission (FTC) says that a June Supreme Court decision finding so-called pay-for-delay patent dispute settlements not inherently anticompetitive has put the agency in a stronger position to protect consumers from such settlements
The Second Circuit Court of Appeals affirmed a New York federal court ruling that scientific opinions in a journal article could not give rise to claims of false advertising
The FDA is reviewing two drug-promotion guidances, according to CDER Office of Drug Promotion director Tom Abrams
FDA director of drug evaluation and research Janet Woodcock says she is amazed that FDA has had more than 30 requests for its new breakthrough therapy designations and it has granted 11 already.
Organization including the Pew Charitable Trusts are voicing basic suppor for FDA's efforts to develop an alternative approval pathway for certain drugs
FDA drug safety officials say that an influx of numerous bleeding reports associated with Boehringer Ingelheim's blood thinner Pradaxa (dabigatran) is a case of "stimulated reporting"
FDA commissioner Margaret Hamburg is urging the pharmaceutical industry to improve manufacturing quality
The idea of scaling back premarket clinical trials comes under fire
FDA is exploring an alternative drug-approval pathway for drugs intended to address unmet medical needs by "limited use" approvals.
FDA commissioner Margaret Hamburg says that if academia, industry, government scientists and regulators could come together more in pre-competitive collaboration it could get more done
A new report says that FDA still has significant workforce and management challenges in the scientific and medical arenas that need to be addressed
An FDA Warning Letter says that oBand Centers is making misleading claims in its promotional materials for the Lap-Band
FDA's drugs center wants to revisit a proposal once entertained by PhRMA to allow the agency access to all data from failed drug development programs to research whether different approaches could have saved the products.
The FDA wants to replace Medication Guides, patient-package inserts, and other consumer medication information handed out at pharmacies with a proposed Patient Medication Information (PMIs) sheet
A White House scientific panel has recommended that FDA expand its accelerated approval program to a broader range of drugs.
The Pharmaceutical Research and Manufacturers of America (PhRMA) has adopted "principles" to guide interactions between companies and patient organizations.
Used for the first time in the recent $3 billion healthcare fraud settlement with GlaxoSmithKline (GSK), a new enforcement tool has joined the federal government's list of options to rein in improper medical product promotion.
FDA challenged a House report that said its regulations and enforcement actions contribute to drug shortages.
An appeals court ruling says "any payment from a patent holder to a generic patent challenger who agrees to delay entry into the market" can be taken as "evidence of an unreasonable restraint of trade."
A new report from the House Committee on Oversight and Government Reform blames FDA for shortages of generic injectable medications.
A Yale assistant professor and a medical student have provided evidence that FDA's review process is faster than those in other countries.
Legislation to speed FDA approval of breakthrough drugs is being supported by both former FDA commissioner Mark McClellan, now a Brookings Institution senior fellow, and Friends of Cancer Research chairperson Ellen Sigal.
An FDA report says the agency issued 68 drug safety alerts in 2011, an average of more than one each week and up 74% over the 39 alerts issued in 2010.