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FDA, Drug Discovery, GMP, GTP, and Pharmacogenomics

  1. Laws Enforced by the FDA and Related Statutes.
  2. Comprehensive List of FDA Guidance Documents, including guidance to Conflict of Interest Disclosure.
  3. 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
  4. Reporting Adverse Reactions and Medical Product Problems to the FDA.
  5. National Drug Code Directory.
  6. Alphabetical list of all FDA links.
  7. ClinicalTrials. Gov. provides regularly updated information about federally and privately supported clinical research in human volunteers.
  8. Drug Discovery Online (industry professional)
  9. Pharmacogenomics: definitions, news.
  10. Pharmacogenetics: definitions, news.