Abstract: Preface Editors Contributors Overview of FDA and Drug Development Josephine C. Babiarz and Douglas Pisano What Is an IND? Michael R. Hamrell The New Drug Application Charles Monahan and Josephine C. Babiarz Meetings with the FDA Alberto Grignolo and Sally Choe FDA Medical Device Regulation Barry Sall A Primer of Drug/Device Law: What Is the Law and How Do I Find It? Josephine C. Babiarz The Development of Orphan Drugs Scott N. Freeman CMC Sections of Regulatory Filings and CMC Regulatory Compliance during Investigational and Postapproval Stages Prabu Nambiar, Steven R. Koepke, and Kevin Swiss Overview of the GxPs for the Regulatory Professional Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters FDA Regulation of the Advertising and Promotion of Prescription Drugs, Biologics, and Medical Devices Karen L. Drake, Esq. The Practice of Regulatory Affairs David S. Mantus FDA Advisory Committees Christina A. McCarthy and David S. Mantus Biologics Florence Kaltovich Regulation of Combination Products in the United States John Barlow Weiner, Esq. Index
Publication Year: 2008
Publication Date: 2008-08-11
Language: en
Type: book
Indexed In: ['crossref']
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Cited By Count: 12
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