Regulations issued by FDA are an important part of enforcing the Federal Food, Drug, and Cosmetic Act. Especially important are such regulations as:
Current Good Manufacturing Practice Regulations, which set requirements for sanitation, inspection of raw materials and finished products, and other quality controls.
New Drug Regulations, which tell drug companies what they must do to get FDA to approve the marketing of a new drug and to assure its continued safety and effectiveness.
The Federal Register is the vehicle through whichh the administrative rulemaking process that is mandated by the Federal Food, Drug and Cosmetic Act and related laws.
The role the Federal Register plays in the
regulatory process is briefly described at the CDER
site.
Types of information of interest include the below:
Advance Notice
Proposed Regulations
Final Regulations
Regulatory Agenda Agenda
Meetings and Hearings
Finding of No Significant Impact (for an Environmental Assessment)
Debarment Procedings
Patern Term Extension
Guideline and Guidance Notices
A Federal Depository Library is a library which, under the auspices of the US Government Printing Office, provides regional access to federal documents.
At the form, select the source of the document, e.g. CFR, FR, etc. and enter the search term. The search delivers documents which must be individually searched.
The CFR is also available directly from the Government
Printing Office . Documents may be viewed with Adobe Acrobat
then saved for local use.
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