The pharmaceutical regulatory process /
| Other Authors: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York :
Marcel Dekker,
[2005]
|
| Series: | Drugs and the pharmaceutical sciences ;
v. 144. |
| Subjects: |
Table of Contents:
- Pharmaceutical regulation before and after the Food, Drug, and Cosmetic Act
- The new drug-approval process--before and after 1962
- FDA regulation of biological products
- Generic drug approval process : pre-1984 history concerning generic drugs
- Generic drug approval process, post-1984 : Hatch-Waxman reform
- Food and Drug Administration Modernization Act
- FDA antibiotic regulatory scheme : then and now
- Pioneer and generic drugs : balance between product life cycle extension and anticompetitive behavior
- The influence of the Prescription Drug User Fee Act on the approval process
- Clinical research requirements for new drug applications
- Active pharmaceutical ingredients
- Obtaining approval of new drug applications and abbreviated new drug applications from a chemistry, manufacturing, and controls perspective
- Obtaining approval of a generic drug
- Current good manufacturing practice and the drug approval process
- CMC post-approval regulatory affairs : constantly managing change
- The influence of the USP on the drug approval process
- Ways and means to U.S. registration of foreign drugs
- Common technical document--quality (M4-Q) : one regulatory participant's perspective
- 21 CFR Part 11 compliance and beyond
- Marketing and advertising/promotion : the impact of government regulations
- Approval and marketing of nonprescription or OTC human drugs