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FDA Issues 48 Product-Specific Bioequivalence Guidances
The FDA has issued dozens of draft and revised draft product-specific guidances that detail its recommendations for bioequivalence (BE) studies to support ANDAs. New draft product-specific BE recommendations are available for 32 drug products. Drugs with the active ingredients amoxicillin, budesonide, linagliptin, omeprazole and paclitaxel are just a few of those listed in the FDA’s Sept. 14 Federal Register notice.
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