Content about Janet Woodcock

December 9, 2013

The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

WASHINGTON — The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

October 25, 2013

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

SILVER SPRING, Md. — 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.

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

In a memo sent out to staff, Center for Drug Evaluation and Research director Janet Woodcock wrote that she would not retire, but was becoming "more deeply involved" in such activities as proposed reorganizations of the Office of Pharmaceutical Quality and the Office of Generic Drugs.

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.

SILVER SPRINGS, Md. — 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.

In a memo to staff of the agency's Center for Drug Evaluation and Research, center director Janet Woodcock wrote that for fiscal year 2013, the FDA hired 234 people as part of the Generic Drug User Fee Amendments Human Capital Team. The goal was to hire 231 as part of a three-year push in which it hopes to hire 921, including 461 during fiscal year 2014.

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.

NEW YORK — 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.

CDER director Janet Woodcock wrote that the FDA had collected more than $255 million under the Generic Drug User Fee Amendments to the 2012 Prescription Drug User Fee Act reauthorization. The agency plans to collect $299 million in fiscal year 2013.

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.

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

In a memo sent out to staff of the Center for Drug Evaluation and Research, the section of the agency that oversees the OGD, CDER director Janet Woodcock wrote that Uhl most recently served as senior adviser to director Greg Geba, who announced his resignation Thursday.

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.

SILVER SPRING, Md. — 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 held here.

May 10, 2011

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

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

Reuters quoted FDA Center for Drug Evaluation and Research director Janet Woodcock as saying the number of drugs approved gradually could increase, already having reached a “nadir.” The report noted that 12 drugs had won approval this year so far, and Woodcock speculated that the agency would approve more than the 21 it approved last year.

November 14, 2010

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

ROCKVILLE, Md. — A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the situation facing the Food and Drug Administration and the generic pharmaceutical industry—and it’s the chief impetus behind the FDA’s push to impose user fees on generic drug makers seeking the agency’s review and approval for their brand-equivalent medicines.

November 14, 2010

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

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

According to published reports, the Food and Drug Administration may be considering adopting tougher standards for certain classes of generic drugs if it determines that some are not equivalent to their branded counterparts.

October 20, 2010

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

BETHESDA, Md. The Food and Drug Administration could decide that some generic drugs are not equivalent to their branded counterparts, according to published reports.

 

September 26, 2010

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