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As part of FDA’s Transparency Initiative and Transparency Results Accountability Credibility Knowledge Sharing (TRACK), the agency is maintaining an updated agenda of upcoming proposed and final rule-making regarding drugs, food, devices, and compounded products. Included in the list of 59 items are 16 from CDER, two from CBER, and eight from CVM. Included are proposed rules on: ● GMPs for compounding outsourcing facilities.● fixed-dose combination and co-packaged drug and/or biological products ● conditional approval of new animal drugs for minor use and minor species, and ● updating tolerances for residues in new animal drugs in food.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
