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