Food, Drug & Safety Laws Course

FDA Law & Related Sites

• The Food & Drug Administration  
  

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

• CFR Title 21
   
  This is the title that applies to the FDA and is from its website.

• FDA Federal Register Notices
   
  Published by the Office of the Federal Register, National Archives and Records Administration (NARA), the Federal Register is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents. It is updated daily by 6 a.m. and is published Monday through Friday, except Federal holidays. FDsys contains Federal Register volumes from 59 (1994) to the present.  Documents are available in Summary, PDF, ASCII text, or HTML format. HTML documents are available from 2000 forward and provide hypertext links to Web sites mentioned in the FR document. The active HTTP-link feature will be added to previous Federal Register databases in the near future. The HTML documents can be saved as text files with no loss or change in data.

• Laws the FDA Enforces
   
  This is the part of the FDA website that contains the laws that the FDA enforces.
   

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Other Sites

• Food & Drug Law Institute

The Food and Drug Law Institute, founded in 1949, is a non-profit organization that provides a marketplace for discussing food and drug law issues through conferences, publications and member interaction. The scope of FDLI includes food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco. FDLI is a not-for-profit 501(c)(3) organization. FDLI does not engage in advocacy activities.

• Laws & Regulations

GPO’s Federal Digital System (FDsys) provides free online access to official publications from all three branches of the Federal Government. Through FDsys, you are able to:

•   Search for documents and publications — FDsys provides advanced search capabilities and the ability to    refine and narrow your search for quick access to the information you need.
•   Browse for documents and publications — FDsys offers browsing by collection, Congressional committee,    date, and Government author.  Access metadata about documents and publications — FDsys provides    information about Government publications in standard XML formats.
•   Download documents and publications in multiple renditions or file formats — With FDsys, users can    download a single file or download content and metadata packaged together in a compressed file.

• Regulations.gov

On Regulations.gov, you can find and comment on proposed regulations and related documents published by the U.S. Federal government.  You can also find: Final Regulations;Notices;Scientific and Technical Findings; Guidance; Adjudication; Comments; and The Unified Agenda and Regulatory Plan.  You will not find: Public Laws (Legislation); Code of Federal Regulations (CFR); State, Local, and Tribal Government Regulations