Purchasing Resources for Pharmaceutical Regulations

Center for Disease Control (CDC)

Database of legislation regarding disease control, publications, health topics, news releases.

http://www.cdc.gov

Center for Drug Evaluation and Research(CDER)

A division of FDA, site contains drug information, regulatory guidance, CDER archives and calendar.

http://www.fda.gov/cder/index.html

Code of Federal Regulations

Codification of the general and permanent rules promulgated by the Executive departments and agencies of the Federal Government and published in the Federal Register.

http://www.access.gpo.gov/nara/cfr/

Department of Health and Family Services(Australia)

Leads the development and implementation of health and aged care services policy to achieve Government policy and directions

http://www.health.gov.au/

Europa Homepage

The official site of European Union. Direct links to related institutions, policies, documents and news.

http://www.europa.eu.int/

European Directorate for the Quality of Medicines - European Pharmacopoeia on

Responsible for monographs and guidelines, as well as the harmonization of the programs for the European community

http://www.pheur.org/

FDA Laws

Compilation of Laws Enforced by the U.S. Food and Drug Administration and Related Statutes

http://www.fda.gov/opacom/laws/lawtoc.htm

FDA: Laws and Regulations

Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration

http://www.fda.gov/opacom/morechoices/smallbusiness/blubook.htm

Federal Food, Drug, and Cosmetic Act

Portions revised or new- As Amended by the FDA Modernization Act of 1997

http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm

National Institute for Biological Standards and Control, NIBSC (UK)

International role in preparing, evaluating and distributing International Biological Standards and other biological reference materials

http://www.nibsc.ac.uk/

New Zealand: Ministry of Health and Information Service

A group within the Ministry of Health responsible for the collection and dissemination of health-related information.

http://www.nzhis.govt.nz/

Prescription Drug User Fee Act Related Documents (3/14/2000)

This site provides documents on various user-fee related issues.

http://www.fda.gov/cder/pdufa/default.htm

Prescription Drug User Fee Act

(PDUFA) of 1992 provided FDA with increasing levels of resources for the review of human drug applications.

http://www.fda.gov/opacom/7pdufa.html

RegSource

Comprehensive site to information resources for the pharmaceutical professionals. The site provides links to regulatory and scientific information on the Internet for drug discovery, development and the drug approval process

http://www.regsource.com/

The Standards Council of Canada

A federal Crown corporation with the mandate to promote efficient and effective standardization.

http://www.scc.ca/