Examines harmonization of the US Federal Meals, Drug, and Magnificence Act with worldwide legal guidelines as they apply to human drug and device enchancment, evaluation, manufacturing, and promoting. The Second Model focuses on the model new drug approval course of, cGMPs, GCPs, high high quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it attracts information from quite a lot of belongings. It demystifies the interior workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.
FDA Regulatory Affairs:
provides a blueprint to the FDA and drug, biologic, and medical device enchancment
provides current, precise-time information in a straightforward and concise format
accommodates a chapter highlighting the model new drug software (NDA) course of
discusses FDA inspection processes and enforcement decisions
consists of contributions from specialists at firms resembling Millennium and Genzyme, important CRO’s corresponding to PAREXEL and the Biologics Consulting Group, and the FDA
Three all-new chapters cowl:
medical trial exemptions
provisions for fast monitor
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