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Statement from FDA on continuing efforts to maintain its strong oversight of generic drugs
date:Feb 25, 2019
ards established for the specific drug.

For example, the FDA labs tested 323 products from around the world including more than 100 from India to determine if foreign manufacturers had a higher incidence of product failure. All 323 samples met U.S. market quality standards using testing standards set by the United States Pharmacopeia (USP) or submitted in marketing applications.

We recognize that the U.S. market for pharmaceuticals has changed dramatically in recent years. In 1990, generic m

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