The Pharmaceutical Regulatory Process
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
LEGAL REQUIREMENTS FOR REGULATORY COMPLIANCE
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
REGULATORY REQUIREMENTS FOR PRODUCT APPROVALS AND AFTER
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