The pharmaceutical regulatory process / edited by Ira R. Berry, Robert P. Martin.

CONTENT

PART I LEGAL REQUIREMENTS FOR REGULATORY COMPLIANCE
1 Pharmaceutical regulation before and after the Food, Drug, and Cosmetic Act
2 Modernizing the Food And Drug Administration
3 The new drug approval- process - before and after 1962
4 Generic drug-approval process - Hatch-Waxman update
5 FDA regulation of biological products
6 FDA's antibiotic regulatory scheme: then and now
7 Generic drugs in a changing intellectual property landscape
8 The influence of the Prescription Drug User Fee Act on the approval process
9 Clinical research requirements for new drug applications
10 Postapproval marketing practices regarding drug safety and pharmacovigilance
11 Drugs marketed without FDA approval
12 FDA regulation of foreign drug imports: the need for improvement

PART II REGULATORY REQUIREMENTS FOR PRODUCT APPROVALS AND AFTER
13 Active pharmaceutical ingredients
14 Obtaining approval of new drug applications and abbreviated new drug applications from chemistry, manufacturing, and controls perspective
15 Obtaining approval of a generic drug, pre-1984 to the present
16 New developments in the approval and marketing of nonprescription or OTC drugs
17 Current good manufacturing practice and the drug approval process
18 The influence of the USP on the drug approval process
19 Ways, Means, and evolving trends in the U.S. registration of drug products from foreign countries
20 Impact of government regulation on prescription drug marketing and promotion
21 CMC postapproval regulatory affairs: constantly managing change
22 Living with 21 CFR part 11 compliance

Includes references and index