Food and Drug Administration www.fda.gov News, Guidance Documents, Dockets, Code of Federal Regulations, and International Activities

FDA Warning Letters www.fda.gov/foi/warning.htm

FDA Inspection Guides www.fda.gov/ora/inspect_ref/igs/iglist.html

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

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

ASTM www.astm.org 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 www.ispe.org 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 www.pda.org 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 www.ivthome.com 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 www.asm.org American Society For Microbiology – Source of information related to the Microbiological field.

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

USP www.usp.org 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 www.fdli.org 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 www.asq.org 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 www.fda.gov/ora/compliance_ref/ This link provides access to documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnel.