Pisano / Mantus FDA Regulatory Affairs

Third Edition
3. Auflage 2014
ISBN: 978-1-84184-920-1
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 400 Seiten

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more.

The Third Edition of this highly successful publication:

- Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing

- Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL

- Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements

- Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V

- Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions

Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

Zielgruppe

Compliance officers; regulatory affairs professionals; researchers in drug discovery and drug development; and pharmaceutical, biotechnology, and medical device engineers, scientists, and manufacturers as well as students, faculty, and academia.

Autoren/Hrsg.

Pisano, Douglas J.

Mantus, David

Fachgebiete

• Rechtswissenschaften Ausländisches Recht Common Law (UK, USA, Australien u.a.)
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Lebensmittelindustrie, Nahrungsmittelindustrie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Kosmetische Technologie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Lebensmitteltechnologie und Getränketechnologie

Inhaltsverzeichnis

Preface

Editors

Contributors

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.

Index

Über Autor(innen)

David Mantus worked in the biotechnology and pharmaceutical industry for more than 20 years. He not only served as vice president of regulatory affairs at Cubist Pharmaceuticals but also held various regulatory roles at Sention Inc., Shire Biologics, PAREXEL, the Massachusetts Public Health Laboratory, the Massachusetts College of Pharmacy and Health Sciences, and Procter and Gamble Pharmaceuticals. He received his BS in chemistry from the College of William and Mary, his MS and Ph.D in chemistry from Cornell University, and was a post-doctoral research fellow in biomedical engineering at the University of Washington. He is currently associate professor of pharmaceutical sciences and director, regulatory affairs at MCPHS University in Boston.

Douglas J. Pisano received his Ph.D in law, policy, and society from Northeastern University. He has participated on the editorial advisory boards of multiple journals and received the Special Service Award for the Enhancement of Regulatory Education from the Regulatory Affairs Professionals Society. A registered pharmacist and active member of several professional organizations, including the American Association of Colleges of Pharmacy and the Regulatory Affairs Professionals Society, he formerly served as dean of the School of Pharmacy–Boston and is currently professor of pharmacy administration, vice-president of academic affairs, and provost at MCPHS University in Boston.