Pharmaceutical Regulations

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FOI - FDA Medical Device Documents
Using the Freedom of Information Act, we've collected over 150,000 documents that record the inner workings of the approval and regulation of medical devices, pharmaceuticals, biologics, veterinary products, foods and cosmetics.

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

 
Department of Health: United Kingdom
The Department of Health's overall aim is to improve the health and well being of the people of England, through the resources available

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

 
Center for Disease Control (CDC)
Database of legislation regarding disease control, publications, health topics, news releases.

 
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

 
Prescription Drug User Fee Act
(PDUFA) of 1992 provided FDA with increasing levels of resources for the review of human drug applications.

 
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

 
Federal Register
Search via GPO Access; the official daily publication for Rules, Proposed Rules, and Notices of Federal agencies and organizations, as well as Executive Orders and other Presidential Documents; the searchable database includes aviation related d.

 
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

 
Medicines Control Agency: United Kingdom
Licensing, quality inspection and enforcement.

 
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.

 
Federal Food, Drug, and Cosmetic Act
Portions revised or new- As Amended by the FDA Modernization Act of 1997

 
British Institute of Regulatory Affairs, BIRA
Regulatory agency with represenation of special interest groups representing particular sectors

 
The Standards Council of Canada
A federal Crown corporation with the mandate to promote efficient and effective standardization.

 
Food and Drug Administration: Clinical Trials and Treatments
The agency is a cosponsor of the AIDS Clinical Trials Information Service.

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

 
Prescription Drug User Fee Act Related Documents (3/14/2000)
This site provides documents on various user-fee related issues.

 
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.

 
EUDRA
The European system for the authorisation of medicinal products for human and veterinary use is designed to promote both public health and the free circulation of pharmaceuticals

 
National Institute for Biological Standards and Control, NIBSC (UK)
International role in preparing, evaluating and distributing International Biological Standards and other biological reference materials

 
Pharmacopoeia.co.uk
Authoritative resource on standards for medicines in the UK

 
Center for Drug Evaluation and Research(CDER)
A division of FDA, site contains drug information, regulatory guidance, CDER archives and calendar.

 
Australian Therapeutic Goods Administration (TGA)
A national framework for regulating therapeutic drugs and devices in Australia and ensuring their quality, safety and efficacy.

 
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