Websites of Interest

FDA Links

Archiving Submissions in Electronic Format

Bioresearch Monitoring Information System (BMIS)

CDER Organizational Chart

CDRH Guidance Documents

CDRH Organization Structure

Clinical Investigator Disqualifications Proceedings

Clinical Investigator Inspection List (CLIIL)

Compounding

Computerized Systems Used in Clinical Trials

Device Advice

Electronic Regulatory Submissions and Review

Expedited Safety Reporting Requirements For Human Drug and Biological Products

FDA Debarred Persons List

FDADockets

FDA Guidance, Compliance & Regulatory Information

FDA Modernization Act of 1997

FD&C Act

Freedom of Information Act

Information for Health Professionals

International Conference on Harmonisation (ICH) Guidance Documents

Investigational Device Exemptions (IDE) (Device Advice)

Laws Enforced by FDA

MedWatch

National Drug Code (NDC) Directory

New and Generic Drug Approvals

Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)

Pediatric Product Development

SQA - Society of Quality Assurance

Warning Letters, Compliance, Enforcement and Criminal Investigations

Non-FDA Links

Clinical Trials Registry

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

HHS Employee and Organizational Directory

Institute of Medicine of the National Academies

Office for Human Research Protections (OHRP)

OHRP IRB Guidebook

PHS Administrative Action Bulletin Board

Presidential Commission for the Study of Bioethical Issues

Secretary’s Advisory Committee on Human Research Protections (SACHRP)

Veterans' Administration Office of Research Oversight (ORO)

Industry Links

AAHRPP - Association for the Accreditation of Human Research Protection Programs

ACRP - Association of Clinical Research Professionals

CenterWatch - Clinical Trials Information

DIA - Drug Information Association

FDA - U.S. Food and Drug Administration

PERI - Pharmaceutical Education & Research Institute