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FDA News

Gaps in Women's Health Research Remain Despite Progress

WASHINGTON, DC—Research into women’s healthcare has improved over the last 20 years, but still lags in several key areas, according to an IoM report released last month.

FDA Starts Early MDUFA Reauthorization Talks

HYATTSVILLE, MD—Even though the Medical Device User Fee Act is not scheduled to expire until September 2012, FDA is already beginning the process of soliciting comments on how the act has worked to date, and how it might be improved.

FDA Adverse Event Reporting, Analysis Being Reviewed

ROCKVILLE, MD—“One of the things the public has problems dealing with is uncertainty and building science around that uncertainty,” declared Jesse Goodman, MD, FDA’s science chief, at a recent meeting of the FDA Science Board.

FDA Recommitting to Regulatory Science

BETHESDA, MD—Efforts in basic science at FDA have, in recent years, been “underappreciated, under resourced, and underfunded,” even though they are an essential component of the agency, FDA Commissioner Margaret Hamburg, MD told the members of FDA’s Science Board at a recent meeting.

Dr. Margaret Hamburg Is New FDA Commissioner

WASHINGTON, D.C.—The Senate confirmed Margaret Hamburg, MD, to lead the Food and Drug Administration last month. The unanimous confirmation came as no surprise considering the ease of her confirmation hearing and her backing by both Democrat and Republican Senate leaders.

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