000			02279nam\a2200325\a\4500
001			57914
005			20260728100835.0
008			260728s2014 flu b 001 0 eng
020			_a978104116396 _qhardcover : acid-free paper
035			_a(DNLM)101621073
040			_aDNLM/DLC _cDLC _erda _dBD-DhIUB
082	0	0	_a61519 _223 _bF287
245	0	0	_aFDA regulatory affairs / _cedited by David Mantus, Douglas J. Pisano.
250			_aThird edition.
260			_aUK: _b CRC Press/Taylor & Francis Group _c2024
300			_axii, 387 pages ; _c24 cm
504			_aIncludes bibliographical references and index.
505	0		_aOverview 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.
526			_aPHR _bphr _lPHAR
541			_aTRIM
610	1	2	_aUnited States. _bFood and Drug Administration.
650	1	2	_aDrug Approval _zUnited States.
650	1	2	_aUnited States Government Agencies _zUnited States.
650	2	2	_aBiological Products _xstandards _zUnited States.
650	2	2	_aEquipment and Supplies _xstandards _zUnited States.
650	2	2	_aGovernment Regulation _zUnited States.
700	1		_aMantus, David, _eeditor of compilation.
700	1		_aPisano, Douglas J., _eeditor of compilation.
942			_2ddc _cBK
999			_c57914 _d58088