Websites of Interest

FDA Links

Archiving Submissions in Electronic Format

Bioresearch Monitoring Information System File: Clinical Investigators, CROs and IRBs from FDA 1571 & 1572s

CDER Guidance Documents

CDER Organizational Chart

CDRH Device Advice

CDRH Organization Structure

Clinical Investigator Disqualifications Proceedings

Computerized Systems Used in Clinical Trials

Drug Approvals List

Electronic Regulatory Submissions and review

Expedited Safety Reporting Requirements Oct 7, 1997 Federal Register Final Rule
click on: (federal register - GPO)(Federal register)(1997)final rule:regulations)enter date: (on 10/07/1997) search terms: (expedited)

FDA Debarred Persons List

FDA Disqualified/Restricted/Assurances List for Clinical Investigators ref/bimo/dis res assur.htm


FDA Letters Providing Clinical Investigators with Notice of Initiation of Disqualification Proceedings and Opportunity to Explain

FDA Modernization Act of 1997

CDRH Guidance

CDER-Related Documents

FD&C Act

Freedom of Information Reading Room

Information for Health Professionals

International Conference on Harmonisation Conference on Harmonisation

Investigational Human Drugs Clinical Investigator Inspection List

Investigational Device Exemptions (IDE) Policies and Procedures

Laws Enforced by FDA


National Drub Code (NDC) directory

New Drug Approval Packages

Orange Book (Approved Drugs)

Pediatric Medicine Page

Pharmacy Compounding

Warning letters

CDER Bioresearch Monitoring

Non-FDA Links

Clinical Trials Registry

Government Printing Office (Federal Register, Code of Federal Regulations, Congressional Record) docs/

HHS Employee and Organizational Directory

Institute of Medicine of the National Academy of Sciences

National Bioethics Advisory Committee

National Human Research Protections Advisory Committee

Office for Human Research Protections

OHRP IRB Guidebook guidebook.htm

PHS List of Investigators Subject to Administrative Action:

Veterans' Administration Office of Research Compliance and Assurance (ORCA)

Industry Links

FDA - U.S. Food and Drug Administration

CENTERWATCH - Clinical Trials Listing Service

DIA - Drug Information Association

PERI - Pharmaceutical Education & Research Institute

ACRP - Association of Clinical Research Professionals