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21 CFR Part 11 Electronic Records/Electronic Signatures Latest Guidance Document

Office of Regulatory Affairs


FDA Talk Papers

FDA Guideline for Computerized Systems Used in Clinical Trials

FDA Guideline for General Principals of Software Validation

Freedom of Information

FOI, Electronic Reading Room

FDA Modernization Act of 1997 (FDAMA)

Human Drug Current Good Manufacturing Practice Notes

Center for Biologics Evaluation and Research

CDER Handbook


Other helpful links

Code of Federal Regulations

U.S. Pharmacopeia

International Society for Pharmaceutical Engineering (ISPE)

National Institute of Standards and Testing

International Society for Measurement and Control

PDA - Parenteral Drug Association

DIA - Drug Information Association


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