By Douglas J. Pisano,David S. Mantus
Examines harmonization of the united states Federal nutrition, Drug, and beauty Act with foreign laws as they practice to human drug and gadget improvement, study, production, and advertising. The Second Edition makes a speciality of the recent drug approval technique, cGMPs, GCPs, caliber process compliance, and corresponding documentation standards. Written in a jargon-free variety, it attracts info from quite a lot of assets. It demystifies the interior workings of the FDA and allows an realizing of the way it operates with admire to compliance and product approval.
FDA Regulatory Affairs:
- provides a blueprint to the FDA and drug, biologic, and scientific gadget development
- offers present, real-time info in an easy and concise format
- contains a bankruptcy highlighting the hot drug software (NDA) process
- discusses FDA inspection tactics and enforcement options
- includes contributions from specialists at businesses reminiscent of Millennium and Genzyme, top CRO’s equivalent to PAREXEL and the Biologics Consulting team, and the FDA
Three all-new chapters cover:
- clinical trial exemptions
- advisory committees
- provisions for quick track
Read Online or Download FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics PDF
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Additional info for FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics by Douglas J. Pisano,David S. Mantus