Clinical Research Resources
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FDA, Drug Discovery, GMP, GTP, and Pharmacogenomics
- Laws Enforced by the FDA and Related Statutes.
- Comprehensive List of FDA Guidance Documents, including guidance to Conflict of Interest Disclosure.
- Current Good Manufacturing Practice Issues on Human Use Pharmaceuticals. Comments on the Proposed Rule for Good Tissue Practice for Manufacturers of Human and Tissue-Based Produts; Inspections and Enforcements.
ICH: Guideline for god clinical practice
GMP: Guide for active pharmaceutical ingredients
- Reporting Adverse Reactions and Medical Product Problems to the FDA.
- National Drug Code Directory.
- Alphabetical list of all FDA links.
- ClinicalTrials. Gov. provides regularly updated information about federally and privately supported clinical research in human volunteers.
- Drug Discovery Online (industry professional)
- Pharmacogenomics: definitions, news.
- Pharmacogenetics: definitions, news.