FDA regulatory affairs
Subtitle: a guide for prescription drugs, medical devices, and biologics
By: edited by Douglas J. Pisano, David S. Mantus.
Contributors: Pisano, Douglas J.; Mantus, David.
Edition: 2nd ed.
Publisher: Informa Healthcare USA
Published: 2008
Place of publication: New York
Language: eng
ISBN-13: 9781420073546
Subjects: United States -- Food and Drug Administration -- Rules and practice.; United States. -- Food and Drug Administration.; Drug development -- United States.; Pharmaceutical industry -- United States.; Drug Industry -- standards -- United States.; United States Government Agencies -- United States.; Biological Products -- standards -- United States.; Equipment and Supplies -- standards -- United States.; Government Regulation -- United States.
Notes: Includes bibliographical references and index.
Table of contents: value: Overview of drug development and the FDA / Josephine Babiarz; value: IND / Michael R. Hamrell; value: Formatting, assembling, and submitting a CTD (NDA) / Charles Monahan III; value: Meeting with the FDA / Alberto Grignolo; value: Biologics / J. Kenimer; value: FDA medical device regulation / Barry Sall; value: The development of orphan drugs / Tan Nguyen; value: Combination products / Tara Dunn; value: Chemistry, manufacturing, and control issues: drugs and biologics / Prabu Nambiar; value: Good clinical practices, good manufacturing practices, and good laboratory practices / Robert Buckley; value: The regulation of promotional materials and advertising for drugs / Karen Drake; value: CTD submissions: a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, Vah Ghahraman; value: The practice of regulatory affairs / Dave Mantus; value: A primer of drug/device law or what's the law and how do I find it? / Josephine Babiarz; value: Advisory committee system at FDA / Christina McCarthy.