Content about Janet Woodcock

March 19, 2013
FDA picks acting director for Office of Generic Drugs

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
FDA opens dialogue of incorporating technology, pharmacy into switch paradigm

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
Report: Number of drug approvals by FDA may increase

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
FDA generic user fees moving closer to reality

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
GPhA responds to possibility of more stringent FDA regulations

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
Report: FDA may consider strengthening generic drug regulations

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
GPhA and FDA to discuss me-too medicines at technical conference

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