INFORMATION BY THERAPEUTIC AREA ------------------------------------------------------------------------------------------------------------------ Click Here For Information By Therapeutic Area

ANTI-MICROBIAL ------------------------------------------------------------------------------------------------------------------ Global Microbial Threats in the 1990s Developing Antimicrobial Drugs General Considerations For Clinical Trials Emerging and Other Communicable Diseases Surveillance and Control Addressing Emerging Infectious Disease Threats American Society for Microbiology Microbiology Jump Station Antimicrobial Use Guidelines

MEDICAL ------------------------------------------------------------------------------------------------------------------ FDA Medical Bulletin NIH Clinical Alerts Medical Association Links JAMA British Medical Journal New Medicines in Development Database

GOOD CLINICAL PRACTICE (GCP) COMPLIANCE ------------------------------------------------------------------------------------------------------------------ Disqualified/Restricted/Assurances List for Clinical Investigators Debarment List Laboratory Procedure Manual PHS Administrative Action Detailed Listing IRB/Clinical Information Sheets Bioresearch Monitoring Information File FDA Compliance Program Guidance FDA Enforcement Report NIH Clinical Alerts British Association of Research Quality Assurance HHS Office of Research Integrity FDA Guideline for Monitoring of Clinical Investigations Society of Quality Assurance

INTERNATIONAL CONFERENCE ON HARMONIZATION (ICH) ------------------------------------------------------------------------------------------------------------------ ICH Site ICH Guidance Documents

WARNING LETTERS ------------------------------------------------------------------------------------------------------------------ Warning Letters and Notice of Violation Letters Warning Letters by Subject Most Recent Warning Letters Warning Letters by Issuing Office Warning Letters Indexed by Date Warning Letters by Company

SUBJECT PROTECTIONS/IRB ------------------------------------------------------------------------------------------------------------------ Clinical Trials and Human Subject Protection Information Sheets IRB/Clinical Investigator PRIM&R National Bioethics Advisory Commission OPRR (HHS Office for Protection from Research Risks) Office of Research Integrity Eubios Ethics Institute (in Japanese): College of American Pathologists General Laboratory Checklist

PEDIATRICS ------------------------------------------------------------------------------------------------------------------ Approved Drug Products- FDA Written Request for Pediatric Studies Antiretroviral HIV Drug Approvals and Pediatric Labeling Information Assent Age 7 CDER Pediatric Drug Development Organization FAQ on Pediatric Exclusivity (505A) Pediatric Medicine Page Pediatric Drug Development Successes and Solutions Pediatric Exclusivity Pediatrics Information

WOMEN'S HEALTH ------------------------------------------------------------------------------------------------------------------ Useful Web Sites Office of Women's Health Women's Health Public Health Service's Office on Women's Health National Women's Health Information Center

PHARMACOKINETICS ------------------------------------------------------------------------------------------------------------------ Pharmacy and Pharmacokinetics Links International Association of Therapeutic Drug Monitoring and Clin Tox

FINANCIAL DISCLOSURE ------------------------------------------------------------------------------------------------------------------ Certification: Form FDA 3454 Disclosure: Form FDA 3455 Financial Disclosure by Clinical Investigators APR99 Guidance for Industry Financial Disclosure by Clinical Investigators

ADVISORY COMMITTEES ------------------------------------------------------------------------------------------------------------------ Agendas Advisory Committee Meeting Transcripts (CDER) Advisory Committees (Index) Transcripts Advisory Committee Meetings List of Advisory Committees and Information Line Numbers 1998 Meeting Transcripts By Center Documents Entered Daily 2000 Documents Entered Daily 1999 Advisory Committee Transcripts/Minutes by Center 2000 Advisory Committee Transcripts/Minutes by Center 1999 Advisory Committee Transcripts/Minutes by Center 1998

CLINICAL TRIAL WEBSITES ------------------------------------------------------------------------------------------------------------------ Research Across America (RAA) Cancer Clinical Trials Listing NIH Clinical Trials Databases NIH National Institute of Allergy & Infectious Diseases Clin Trial Database National Heart, Lung & Blood Institute Studies Seeking Patients Clinical Research Investigator Registry Royal Pharmaceutical Society of Great Britain AEGIS Clinical Trials Knowledgebase AIDS Vaccine Evaluation Group (AVEG) Cancer Clinical Trials Clinical Investigator's Handbook (NCI) Asian Harm Reduction Network HIV/AIDS Resources HPB Clinical Trials

CLINICAL ASSOCIATIONS ------------------------------------------------------------------------------------------------------------------ Association of Clinical Research Professionals (ACRP) American Medical Association - AMA American Medical Informatics Association - AMIA