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FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are about 50 such guidances planned. Below are a few highlights for the drug-manufacturing space. In biopharmaceutics and biosimilarity: • Food-Effect Bioavailability and Fed Bioequivalence Studies— Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Submitted in New […]
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