News, Guidance Documents, Dockets, Code of Federal Regulations, and International Activities
ClinicalTrials.gov provides regularly updated information about federally and privately supported clinical research in human volunteers.
NIST's mission is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life.
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, 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 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.
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.
American Society For Microbiology – Source of information related to the Microbiological field.
BioSpace is globally recognized as the leading provider of web-based resources and information to the life science industry.
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.
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.
The American Society for Quality (ASQ), headquartered in Milwaukee, Wisconsin, USA, is the world’s leading authority on quality since 1946.
This link provides access to documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnel.