Wednesday, January 30, 2019

12/14/2018Hangzhou Guoguang Touring Commodity Co.,Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *

Statement from FDA Commissioner Scott Gottlieb, M.D., on 2019 efforts to advance the development of complex generics to improve patient access to medicines


As part of the FDA’s efforts to promote drug competition and patient access, we’ve advanced many policies aimed at making it more efficient to bring generic competition to the market. We’ve been especially focused on a category of medicines known as complex drugs. These are drugs that, by nature of their formulation, delivery systems or the complexity of their active ingredients, for example, are harder to ...

Athens County Farmer Pleads Guilty to Having Contaminated Calf Slaughtered for Beef

CINCINNATI – Cory L. Gillette, 31, of Albany, Ohio, pleaded guilty in U.S. District Court to having a medicated calf slaughtered with the intention of selling it as beef for human consumption. The calf was contaminated with Gentamicin, which is not approved for use in cattle.

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To close out 2018, FDA published a revised draft guidance on human ...

Lexology-1 hour ago
In accordance with the United States Food & Drug Administration's (“FDA”) 2018 Compounding Policy Priorities Plan, on December 11, 2018, FDA published its .