Food and Drug Administration News, Guidance Documents, Dockets, Code of Federal Regulations, and International Activities

FDA Warning Letters

FDA Inspection Guides

Clinical Trials provides regularly updated information about federally and privately supported clinical research in human volunteers.

NIST NIST's mission is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life.

ASTM ASTM International is one of the largest voluntary standards development organizations in the world-a trusted source for technical standards for materials, products, systems, and services.

ISPE ISPE, the International Society for Pharmaceutical Engineering, is a global, not-for-profit membership organization that provides education, training, and technical publications to pharmaceutical manufacturing professionals.

PDA PDA is a non-profit international association of more than 10,500 scientists involved in the development, manufacture, quality control and regulation of pharmaceuticals/biopharmaceuticals and related products.

IVT The Institute of Validation Technology (IVT) publisher of the Journal of Validation Technology® and the Journal of GXP Compliance®, is dedicated to expanding the global knowledge base for validation and compliance professionals in FDA-regulated industries.

ASM American Society For Microbiology – Source of information related to the Microbiological field.

Biospace BioSpace is globally recognized as the leading provider of web-based resources and information to the life science industry.

USP The United States Pharmacopeia (USP) is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States.

Food Drug and Law Institute The Food and Drug Law Institute is committed to providing high quality education and a neutral forum for the generation of ideas and discussion of law and public policy for its legal, policy and regulatory communities.

American Society for Quality The American Society for Quality (ASQ), headquartered in Milwaukee, Wisconsin, USA, is the world’s leading authority on quality since 1946.

Office of Regulatory Affairs Compliance References This link provides access to documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnel.