FDA approved 35 new drugs during the latest fiscal year
By
Matthew Arnold
Dec 01, 2011
The Food and Drug Administration green-lighted a bumper crop of new medicines in fiscal year 2011. It happened due to expedited approval authorities, flexibility in clinical trial requirements and PDUFA...
FDA agrees to deal that speeds reviews
By
Matthew Arnold
Oct 01, 2011
The Food and Drug Administration and the biopharma industry have agreed in principle on a revamp of the Prescription Drug User Fee Act, by which drug firms provide nearly two-thirds of what the agency...
Pfizer mulls possible OTC Lipitor switch
By
Matthew Arnold
Sep 01, 2011
Pfizer is reportedly weighing an attempt at an over-the-counter switch for Lipitor — a move that could help the company recoup some of its losses when the $11 billion drug loses nationwide exclusivity...
Suggested device approval revamp gets shrug from FDA
By
Matthew Arnold
Sep 01, 2011
The Food and Drug Administration is moving cautiously on a call by the Institute of Medicine to scrap the approvals process currently used for many medical devices.
Drug firms seek off-label help from FDA
By
Matthew Arnold
Aug 02, 2011
Seven large drug firms filed a citizen petition with the Food and Drug Administration that seeks guidance on communication about off-label uses.
CBO: Stopping DTC ads will be mixed bag
By
Matthew Arnold
Jul 01, 2011
How much of an impact would a two-year moratorium on consumer advertising of new drugs have on drug pricing and public health? Not much, and it could go both ways, said the Congressional Budget Office,...
Facebook to drug companies: Enable comments by Aug. 15
By
Matthew Arnold
Jul 01, 2011
Facebook officials have told drug firms that they can no longer obstruct commenting on their pages.
Data firms, drug manufacturers like odds
By
Matthew Arnold
Jun 01, 2011
Data firms and drug manufacturers are feeling confident after the Supreme Court arguments on Vermont’s physician data ban.
Mobile mania: Smartphone users dialing up health info
By
Matthew Arnold
Jun 01, 2011
Another day, another batch of survey data showing that smartphones have become the proverbial tail wagging the dog in medical media.