This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. New chapters cover: the marketing of ...
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This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. New chapters cover: the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance pharmacovigilance programs designed to prevent widespread safety issues legal issues surrounding the sourcing of foreign APIs the issues of counterfeit drugs updates on quality standards
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Add this copy of The Pharmaceutical Regulatory Process to cart. $97.15, new condition, Sold by Booksplease rated 4.0 out of 5 stars, ships from Southport, MERSEYSIDE, UNITED KINGDOM, published 2019 by CRC Press.
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New. Contains: Illustrations, black & white. Drugs and the Pharmaceutical Sciences . Includes: illustrations, black & white. Intended for professional and scholarly audience.
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Add this copy of The Pharmaceutical Regulatory Process (Drugs and the to cart. $139.33, new condition, Sold by Bonita rated 4.0 out of 5 stars, ships from Santa Clarita, CA, UNITED STATES, published 2019 by CRC Press.