General Biologics and Devices, Proposed and Final Orders, Notices, Proposed and Final Rules
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Notices
Proposed Orders
None
Final Orders
Proposed Rules
None
Final Rules
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Use of Symbols in Labeling
4/28/2017 -
Final Rule - FDA Regulations; Change of Addresses; Technical Amendment
4/3/2015 -
Use of Certain Symbols in Labeling
4/19/2013 -
Final Rule - Current Good Manufacturing Practice Requirements for Combination Products
1/22/2013 -
Final Rule - Amendments to Sterility Test Requirements for Biological Products; Correction
5/24/2012 -
Final Rule - Amendments to Sterility Test Requirements for Biological Products
5/3/2012 -
Final Rule - Revision of the Requirements for Constituent Materials
4/13/2011 -
Final Rule - Revision of Organization and Conforming Changes to Regulations
4/1/2010 -
Final Rule - Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment.
4/1/2010 -
Revision of the Requirements for Publication of License Revocation; Confirmation of Effective Date
8/21/2009 -
Expanded Access to Investigational Drugs for Treatment Use, Final Rule (Federal Register)
8/13/2009 -
Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
9/8/2008 -
FDA Regulations; Technical Amendment
8/25/2008 -
Revision of the Requirements for Spore-Forming Microorganisms; Confirmation of Effective Date
5/14/2004 -
Revision of the Requirements for Spore-Forming Microorganisms
12/30/2003 -
Revision to the General Safety Requirements for Biological Products
3/4/2003 -
Biological Products: Reporting of Biological Product Deviations in Manufacturing
11/9/2000 -
Biological Products: Reporting of Biological Product Deviations in Manufacturing (Final Rule)
11/7/2000 -
Revisions to the General Safety Test Requirements for Biological Products
8/5/1998 -
Revisions to the General Safety Requirements for Biological Products
4/20/1998