Clinical Research Resources

Site Map Investigators Log-in

FDA, Drug Discovery, GMP, GTP, and Pharmacogenomics

  1. Laws Enforced by the FDA and Related Statutes.
    http://www.fda.gov/opacom/laws/
  2. Comprehensive List of FDA Guidance Documents, including guidance to Conflict of Interest Disclosure.
    http://www.fda.gov/opacom/morechoices/industry/guidedc.htm
  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
    http://www.fda.gov/cder/dmpq/cgmpnotes.htm
  4. Reporting Adverse Reactions and Medical Product Problems to the FDA.
    http://www.fda.gov/medwatch/how.htm
  5. National Drug Code Directory.
    http://www.fda.gov/cder/ndc/database/Default.htm
  6. Alphabetical list of all FDA links.
    http://www.fda.gov/opacom/hpchoice.html
  7. ClinicalTrials. Gov. provides regularly updated information about federally and privately supported clinical research in human volunteers.
    http://www.clinicaltrials.gov/
  8. Drug Discovery Online (industry professional)
    http://www.drugdiscoveryonline.com/IndustrySearch/SearchResults.aspx?keyword=Pharmacology&ATC~C=001+S=001+R=001+L=a
  9. Pharmacogenomics: definitions, news.
    http://www.ornl.gov/sci/techresources/Human_Genome/medicine/pharma.shtml
  10. Pharmacogenetics: definitions, news.
    http://www.dartmouth.edu/~dmsheart/genetics/pharm/pharm.html