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Federal Food Drug and Cosmetic Act (FFDCA) Drug Compounding Biologics

Akin Gump Strauss Hauer & Feld LLP

FDA Issues Additional Guidance Documents for Compounding Pharmacies and Outsourcing Facilities; Addresses Repackaging

The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more

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