October 25, 2013

The Food and Drug Administration plans to recommend stronger regulations for a commonly used opioid painkiller.

October 10, 2013

One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

September 11, 2013

The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.

June 18, 2013

The Food and Drug Administration's Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

March 19, 2013

The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said.

March 22, 2012

The Food and Drug Administration's director of the Center for Drug Evaluation and Research, Janet Woodcock, on Thursday identified three tools the agency wanted to use in potentially increasing access to appropriate medicines in her opening remarks at the FDA Rx-to-OTC Switch Hearing.

May 10, 2011

The Food and Drug Administration expects to approve an increasing number of drugs, according to published reports.

November 14, 2010

A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the...

November 14, 2010

A ghost from 2008 soon could come back to haunt 2010....

October 20, 2010

The Food and Drug Administration could decide that some generic drugs are not equivalent to...

September 26, 2010

More than a dozen top Food and Drug Administration officials will meet with generic drug...