FDA regulatory affairs. (2014)

• Record Type: Book
• Further Information: Note: Editors, Douglas J. Pisano, David Mantus.
• Editors: Pisano, Douglas J; Mantus, David
• Contents: 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 -- The practice of regulatory affairs / David S. Mantus -- FDA advisory / Christina A. McCarthy and David S. Mantus -- Biologics / Florence Kaltovich -- Regulation of combination products in the United States / John Barlow Weiner.
• Publisher Details: Boca Raton : Taylor & Francis
• Publication Date: 2014
• Extent: 1 online resource
• Subjects: 615/.19; Drug development; Drug Approval; United States Government Agencies; Biological Agents -- standards; Equipment and Supplies -- standards; Government Regulation; MEDICAL -- Pharmacology; Drug development; United States; Electronic books
• Languages: English
• ISBNs: 9781841849201; 1841849200
• Related ISBNs: 9781841849195; 1841849197
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.