Guidance for industry 21 CFR, part 11, electronic records : electronic signatures, electronic copies of electronic records

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine, 2002

Guidance for industry. Part 11, electronic records electronic signatures, scope and application

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2003

Guidance for industry computerized systems used in clinical trials

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Nutrition : Center for Veterinary Medicine : Office of Regulatory Affairs, 1999

Guidance for industry drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 2002