2nd Edition

The Pharmaceutical Regulatory Process

Edited By Ira R. Berry, Robert P. Martin Copyright 2008
    492 Pages 35 B/W Illustrations
    by CRC Press

    490 Pages 35 B/W Illustrations
    by CRC Press

    This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.

    New chapters cover:

    • the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance
    • pharmacovigilance programs designed to prevent widespread safety issues
    • legal issues surrounding the sourcing of foreign APIs
    • the issues of counterfeit drugs
    • updates on quality standards


    Pharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act John P. Swann
    Modernizing the Food and Drug Administration Arthur Y. Tsien, Esq.
    The New Drug–Approval Process—Before and After 1962 Michael P. Peskoe
    Generic Drug-Approval Process: Hatch–Waxman Update Marc S. Gross, Jay Lessler, S. Peter Ludwig, and Amanda L. Vaught
    FDA Regulation of Biological Products Michael S. Labson, Krista Hessler Carver, and Marie C. Boyd
    FDA’s Antibiotic Regulatory Scheme: Then and Now Irving L. Wiesen, Esq.
    Generic Drugs in a Changing Intellectual Property Landscape Neil F. Greenblum, Esq., Michael J. Fink, Esq., Stephen M. Roylance, Esq., P. Branko Pejic, Esq., Sean Myers-Payne, Esq., and Paul A. Braier, Esq.
    The Influence of the Prescription Drug User Fee Act on the Approval Process Marc J. Scheineson, Esq.
    Clinical Research Requirements for New Drug Applications Gary L. Yingling, Esq., and Ann M. Begley, Esq.
    PostapprovalMarketing Practices Regarding Drug Safety and Pharmacovigilance Robert P. Martin
    DrugsMarketedWithout FDA Approval Jane Baluss and David Rosen
    FDA Regulation of Foreign Drug Imports: The Need for Improvement Benjamin L. England

    Active Pharmaceutical Ingredients
    Max S. Lazar
    Obtaining Approval of New Drug Applications and Abbreviated New Drug Applications from a Chemistry, Manufacturing, and Controls Perspective Dhiren N. Shah
    Obtaining Approval of a Generic Drug, Pre-1984 to the Present Loren Gelber
    New Developments in the Approval and Marketing of Nonprescription or OTC Drugs William J. Mead
    Current Good Manufacturing Practice and the Drug Approval Process Ira R. Berry
    The Influence of the USP on the Drug Approval Process Edward M. Cohen
    Ways,Means, and Evolving Trends in the U.S. Registration of Drug Products from Foreign Countries Alberto Grignolo
    Impact of Government Regulation on Prescription DrugMarketing and Promotion Daniel Glassman, Gene Goldberg, and Barbara Spallitta
    CMC Postapproval Regulatory Affairs: Constantly Managing Change Leo J. Lucisano, Kevin A. Miller, and Lorien Armour
    Living with 21 CFR Part 11 Compliance Richard L. Burcham


    IRA R. BERRY is President and Founder of International Regulatory Business Consultants, L.L.C., Freehold, New Jersey, USA. Ira Berry received his M.A. in Biology from Hofstra University, Hempstead, New York, USA and his M.B.A. in Management from Adelphi University, Garden City, New York, USA. He has created a consulting business with his extensive experience in the global areas of pharmaceutical manufacturing operations, quality systems, compliance, regulatory affairs and business development—for APIs and dosage forms. He provides instructions and conducts plant audits for CGMP compliance, quality systems evaluation, SOPs, preparing and filing Drug Master Files and dosage form product registrations and personnel training. His professional affiliations include his membership in the Generic Pharmaceutical Association and International Generic Pharmaceutical Association. Berry has worked extensively with Development and Task Force committees with the FDA and is a recognized health care manufacturing industry expert. He was Co-editor of Informa Healthcare’s first edition of The Pharmaceutical Regulatory Process, as well as the titles Pharmaceutical Process Validation and Validation of Active Pharmaceutical Ingredients. Berry also contributed to several chapters in the Encyclopedia of Pharmaceutical Technology.

    ROBERT P. MARTIN is a consultant at RPMartin Consulting, Lebanon, Pennsylvania, USA. Dr. Martin received both his M.S. and Ph.D degrees from the University of California, Riverside, California, USA. Throughout his career, he has held positions at many pharmaceutical companies, including Forest Laboratories (as Associate Director of Quality Assurance), Duramed Pharmaceuticals (as Director of Quality Services), Merck & Co. (as Senior Scientist), and Johnson & Johnson (in several positions, including Manager of Quality Services). In these positions, he led efforts to improve performance in Research and Development by developing and implementing compliance and quality systems. At his consulting firm, he currently provides an array of pharmaceutical consulting services, including, such as vendor risk analysis and management, bioanalytical and analytical laboratory qualification/validation, manufacturing qualification/validation, auditing, documentation, CMC preparation, DMF preparation, and training.