TY  - BOOK
AU  - Mantus,David
AU  - Pisano,Douglas J.
TI  - FDA regulatory affairs
SN  - 978104116396
U1  - 61519 23
PY  - 2024///
CY  - UK
PB  -  CRC Press/Taylor & Francis Group
KW  - United States
KW  - Food and Drug Administration
KW  - Drug Approval
KW  - United States Government Agencies
KW  - Biological Products
KW  - standards
KW  - Equipment and Supplies
KW  - Government Regulation
N1  - Includes bibliographical references and index; 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; PHR; phr
ER  -