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USP 33 NF 28
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Drug Industry Act of 1962
Considers the following bills to amend the Federal Food, Drug, and Cosmetic Act. H.R. 11581, the Drug and Factory Inspection Amendments of 1962, to require manufacturers to follow certain research, production and marketing safety procedures. H.R. 11582, the Cosmetics and Therapeutic Devices Amendments of 1962, to require safety certification for cosmetics and medical devices; to require labeling on containers containing hazardous substances; and to strengthen controls on food and animal feed additives.
Leachables and Extractables Handbook
A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) such as metered dose inhalers, dry powder inhalers, and nasal sprays pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize...
FDA Veterinarian
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Specification of Drug Substances and Products
Specification of Drug Substances and Drug Products is a fully comprehensive reference on Specification Setting for Pharmaceuticals. There have been several recent developments in the ICH Guidelines, which were not captured in previous editions, notably the new guideline on Development of Analytical Procedure and the revisions to the validation guidelines, and the specification guidelines. This edition contains chapters discussing the unique requirements for the universal critical quality attributes, as well as the specific tests required to characterize and control different types of products, ranging in complexity from small molecules in immediate release oral dosage forms to complex produc...
