General Biologics, Notices, Proposed and Final Rules
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Notices
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Federal Register Notice: Program for Parallel Review of Medical Devices
10/24/2016 -
Federal Register Notice: Electronic Submission of Lot Distribution Reports; Guidance for Industry
3/23/2015 -
Federal Register Notice: Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry
3/20/2015 -
Federal Register Notice: Guidance for Industry: Lupus Nephritis Caused By Systemic Lupus Erythematosus - Developing Medical Products for Treatment; Notice; withdrawal.
6/2010 (This guidance has been withdrawn) -
Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
9/27/2011 -
Guidance for Industry on Process Validation: General Principles and Practices; Availability
1/25/2011 -
2010 FDA Guidance Agenda
12/7/2010 -
Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation
9/7/2010
Proposed Rules
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Proposed Rule: Revocation of the Test for Mycoplasma
4/2/2019 -
FR Proposed Rule: Designation of Official Names and Proper Names for Certain Biological Products
8/28/2015 -
FR Proposed Rule: Medical Device Classification Procedures - DOC # 2014-06364
3/25/2014 -
FR Proposed Rule: Amendments to Sterility Test Requirements for Biological Products, June 21, 2011
6/21/2011 -
Disqualification of a Clinical Investigator; Proposed Rule (Federal Register)
4/13/2011 -
Proposed Rule - Revision of the Requirements for Constituent Materials
3/30/2010 -
Proposed Rule - Reporting Information Regarding Falsification of Data (Feb. 19, 2010)
2/19/2010 -
Revision of the Requirements For Spore-Forming Microorganisms; Companion to Direct Final Rule
12/30/2003 -
Safety Reporting Requirements for Human Drug and Biological Products; Proposed Rule
3/14/2003
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