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FDA Generic Drugs Office’s Scientific Advisory Team Will Direct Research

Executive Summary

Studies of bioequivalence methods by FDA's Office of Generic Drugs will be directed by its Research Initiatives Committee

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FDA will withdraw draft guidance on dermatopharmacokinetics. "We are going to focus on a variety of other methods that make it possible for bioequivalence" for topical dermatologic products, Office of Pharmaceutical Science Acting Director Helen Winkle told the Generic Pharmaceutical Association's annual meeting in Coral Gables, Fla., April 10. "This is not to say that DPK is completely off the radar screen - we will continue to look at it - but we felt like we wanted to get the guidance out of publication." The agency has been considering alternatives following an unfavorable advisory committee meeting (1"The Pink Sheet" Dec. 17, 2001, p. 40)...

Generic Drug Patent Challenge Notifications Will Be Announced By FDA

FDA will soon begin posting announcements of ANDAs that have been filed with Paragraph IV certification on the Office of Generic Drugs web site.




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