FDA Regulatory Affairs : Third Edition (Paperback, 3 ed)

Overview of FDA and Drug Development. What Is an IND? The New Drug Application. Meetings with the FDA. FDA Medical Device Regulation. A Primer of Drug/Device Law: What Is the Law and How Do I Find It? The Development of Orphan Drugs. CMC Sections of Regulatory Filings and CMC Regulatory Compliance during Investigational and Postapproval Stages. Overview of the GxPs for the Regulatory Professional. FDA Regulation of the Advertising and Promotion of Prescription Drugs, Biologics, and Medical Devices. The Practice of Regulatory Affairs. FDA Advisory Committees. Biologics. Regulation of Combination Products in the United States.