FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics /: a guide for prescription drugs, medical devices, and biologics. (©2008)

• Record Type: Book
• Further Information: Note: Edited by Douglas J. Pisano, David S. Mantus.
• Other Names: Pisano, Douglas J; Mantus, David
• Contents: Overview of FDA and drug development / Josephine C. Babiarz and Douglas J. Pisano -- What is an IND / Charles Monahan and Josephine C. Babiarz -- Meeting with the FDA / Alberto Grignolo -- FDA medical device regulation / Barry Sall -- The development of orphan drugs / Tan T. Nguyen -- CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval states / Prabu Nambiar and Steven R. Koepke -- Overview of the GxPs for the regulatory professional / Bob Buckley and Robert Blanks -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- Electronic submissions--a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, and Vahé Ghahraman -- The practice of regulatory affairs / David S. Mantus -- A primer of drug/device law : what's the law and how do I find it / Josephine C. Babiarz -- FDA advisory committees / Christina A. McCarthy and David S. Mantus -- Biologics / Timothy A. Keutzer.
• Edition: 2nd ed
• Publisher Details: New York : Informa Healthcare USA
• Publication Date: 2008
• Copyright Date: 2008
• Extent: 1 online resource (viii, 448 pages), illustrations
• Subjects: 615/.19; Drug development -- United States; Pharmaceutical industry -- United States; Drug Approval; United States Government Agencies; Biological Agents -- standards; Equipment and Supplies -- standards; Government Regulation; MEDICAL -- Drug Guides; MEDICAL -- Pharmacology; MEDICAL -- Pharmacy; MEDICAL -- Nursing -- Pharmacology; Drug development; Pharmaceutical industry; United States; United States; Electronic books; Rules; Rules and practice
• Languages: English
• ISBNs: 9781420073553; 1420073559
• Related ISBNs: 1420073540; 9781420073546
• 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.