Proposed / Final Rules

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2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 and earlier

Guidances / Guidelines / Points to Consider

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2008

FEDERAL REGISTER: Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals, Final Rule - 9/8/2008

FEDERAL REGISTER: FDA Regulations; Technical Amendment; Final Rule - 8/25/2008

FEDERAL REGISTER: Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices; Final Rule - 8/22/2008

FEDERAL REGISTER: Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials; Final Rule - 7/15/2008

FEDERAL REGISTER: Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications; Final Rule - 7/10/2008

FEDERAL REGISTER: Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback" - 6/24/2008

FEDERAL REGISTER: Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling; Proposed Rule - 5/29/2008

FEDERAL REGISTER: Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application; Final Rule - 4/29/2008

FEDERAL REGISTER: Revision of the Requirements for Live Vaccine Processing; Direct Final Rule; Confirmation of Effective Date - 3/7/2008

FEDERAL REGISTER: Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Confirmation of Effective Date and Technical Amendment; Direct Final Rule - 2/8/2008

FEDERAL REGISTER: Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Extension of Comment Period; Proposed Rule - 1/11/2008

2007

FEDERAL REGISTER: Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile; Interim Final Rule; Request for Comments - 12/28/2007

FEDERAL REGISTER: Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle; Final Rule - 11/30/2007

FEDERAL REGISTER: Applications for Food and Drug Administration Application Approval to Market a New Drug; Revision of Postmarketing Reporting Requirements; Final Rule - 10/18/2007

FEDERAL REGISTER: Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection ("Lookback"); Final Rule - 8/24/2007

FEDERAL REGISTER: Medical Devices: Immunology and Microbiology Devices: Classification of In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay; Final Rule - 8/8/2007

FEDERAL REGISTER: Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling; Final Rule - 6/19/2007

FEDERAL REGISTER: Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Final Rule - 3/12/2007

FEDERAL REGISTER: Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container; Final Rule - 1/31/2007

Federal Register: Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Proposed Rule - 1/12/2007

2006

Federal Register: Medical Device Regulations; Disqualification of a Clinical Investigator; Final Rule; Technical Amendment - 12/22/2006

Federal Register: Expanded Access to Investigational Drugs for Treatment Use; Proposed Rule - 12/13/2006

Federal Register: Charging for Investigational Drugs; Proposed Rule - 12/13/2006

Federal Register: Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Delay of Applicability Date; Final Rule; Delay of Applicability Date - 11/13/2006

  • FEDERAL REGISTER Distribution of Blood Derivatives by Registered Blood Establishments that Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements and Administrative Procedures; Proposed Rule - 2/1/2006 - (PDF), (Text)

FEDERAL REGISTER Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs; Proposed Rule - 8/29/2006 - (PDF), (Text)

FEDERAL REGISTER Medical Device Regulations; Addresses; Technical Amendment; Final rule; technical amendment - 7/25/2006 - (PDF), (Text)

FEDERAL REGISTER: Revocation of Status of Specific Products; Group A Streptococcus; Confirmation of Effective Date - 4/21/2006 - (PDF), (Text)

  • FEDERAL REGISTER Revocation of Status of Specific Products; Group A Streptococcus; Direct Final Rule - 12/2/2005 - (PDF), (Text)

  • FEDERAL REGISTER Revocation of Status of Specific Products; Group A Streptococcus; Companion Document to Direct Final Rule; Proposed Rule - 12/2/2005 - (PDF), (Text)

Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Correction - 3/24/2006 - (PDF), (Text)

FEDERAL REGISTER Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products; Final Rule - 1/18/2006 - (PDF), (Text)

2005

FEDERAL REGISTER Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Final Rule and Final Order - 12/15/2005 - (PDF), (Text)

FEDERAL REGISTER Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order - 12/15/2005 - (PDF), (Text)

FEDERAL REGISTER Investigational New Drugs: Export Requirements for Unapproved New Drug Products; Final Rule - 11/23/2005 - (PDF), (Text)

FEDERAL REGISTER Definition of Primary Mode of Action of a Combination Product; Final Rule - 8/25/2005 - (PDF), (Text)

FEDERAL REGISTER Food and Drug Administration Regulations; Drug and Biological Product Consolidation; Addresses; Final Rule; Technical Amendment - 3/24/2005 - (PDF), (Text)

2004

FEDERAL REGISTER Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement; Final Rule - 11/18/2004 - (PDF), (Text)

FEDERAL REGISTER Revision of the Requirements for Spore-Forming Microorganisms; Direct Final Rule; Confirmation of Effective Date - 5/14/2004 - (PDF), (Text)

  • FEDERAL REGISTER Revision of the Requirements for Spore-Forming Microorganisms; Direct Final Rule - 12/30/2003 - (PDF), (Text)

  • FEDERAL REGISTER Revision of the Requirements For Spore-Forming Microorganisms; Companion to Direct Final Rule; Proposed Rule - 12/30/2003 - (PDF), (Text)

FEDERAL REGISTER Supplements and Other Changes to an Approved Application; Final Rule - 4/8/2004 - (PDF), (Text)

FEDERAL REGISTER Bar Code Label Requirement for Human Drug Products and Biological Products; Final Rule; Correction - 4/7/2004 - (PDF), (Text)

  • FEDERAL REGISTER Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule - 2/26/2004 - (PDF), (Text)

FEDERAL REGISTER Emergency Use of an Investigational New Drug; Final Rule; Technical Amendment - 4/6/2004 (PDF), (Text)

FEDERAL REGISTER Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Final Rule; Delay of Effective Date; Correction - 3/18/2004 - (PDF), (Text)

  • FEDERAL REGISTER Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Final Rule; Delay of Effective Date - 2/19/2004 - (PDF), (Text)

  • FEDERAL REGISTER Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Final Rule; Delay of Effective Date - 1/31/2003 - (PDF), (Text)

  • FEDERAL REGISTER Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Final Rule; Delay of Effective Date - 2/13/2002 - (PDF), (Text)

  • FEDERAL REGISTER Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Final Rule; Delay of Effective Date - 3/1/2001 - (PDF), (Text)

  • FEDERAL REGISTER Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Final Rule; Delay of Effective Date; Reopening of Administrative Record. - 5/3/2000 - (PDF), (Text)

  • FEDERAL REGISTER Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Final Rule - 12/3/1999 - (PDF), (Text)

FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Interim Final Rule; Correction - 1/30/2004 - (PDF), (Text)

  • FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Interim Final Rule; Opportunity for Public Comment - 1/23/2004 - (PDF), (Text)

  • FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Final rule; delay of effective date - 1/21/2003 - (PDF), (Text)

  • FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Final Rule - 1/19/2001- (PDF), (Text)

2003

FEDERAL REGISTER Neurological Devices; Classification of Human Dura Mater; Final Rule - 12/18/2003 - (PDF), (Text)

FEDERAL REGISTER Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format; Final Rule - 12/11/2003 - (PDF), (Text)

FEDERAL REGISTER Medical Devices; Immunology and Microbiology Devices; Classification of the West Nile Virus IgM Capture Elisa Assay - Final Rule - 10/30/2003 - (PDF), (Text)

FEDERAL REGISTER Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma; Correction - Proposed Rule; correction - 10/27/2003 - (PDF), (Text)

  • FEDERAL REGISTER Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma - Proposed Rule - 7/30/2003 - (PDF), (Text)

FEDERAL REGISTER Assignment of Agency Component for Review of Premarket Applications - Final Rule - 6/23/2003 - (PDF), (Text)

FEDERAL REGISTER New Drug, Antibiotic, and Biological Drug Product Regulations; Accelerated Approval; Technical Amendment - Final Rule; Technical Amendment - 6/11/2003 - (PDF), (Text)

FEDERAL REGISTER Safety Reporting Requirements for Human Drug and Biological Products; Proposed Rule - 3/14/2003 - (PDF), (Text)

FEDERAL REGISTER Revision to the General Safety Requirements for Biological Products; Final Rule - 3/4/2003 - (PDF), (Text)

  • FEDERAL REGISTER Revisions to the General Safety Test Requirements for Biological Products; Final Rule - 8/5/1998 - (PDF), (Text)

  • FEDERAL REGISTER Revisions to the General Safety Requirements for Biological Products; Direct Final Rule - 4/20/1998 - (PDF), (Text)

2002

FEDERAL REGISTER Import for Export; Reporting and Recordkeeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Subsequent Export; Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission Into the United States; Withdrawal; Proposed Rules; Withdrawal - 8/21/2002 - (PDF), (Text)

  • FEDERAL REGISTER Import for Export; Reporting and Recordkeeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Subsequent Export; Proposed Rule - 11/24/1998 - (PDF), (Text)

FEDERAL REGISTER Postmarket Surveillance; Final Rule - 6/6/2002 - (PDF), (Text)

FEDERAL REGISTER New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible; Final Rule - 5/31/2002 - (PDF), (Text)

  • Concept Paper: Animal Models — Essential Elements to Address Efficacy Under the Animal Rule (PDF) - 9/9/2008

FEDERAL REGISTER Exports; Notification and Recordkeeping Requirements; Stay; Final Rule; Stay - 5/14/2002 - (PDF), (Text)

  • FEDERAL REGISTER Exports: Notification and Recordkeeping Requirements; Final Rule - 12/19/2001 - (PDF), (Text)

FEDERAL REGISTER Obtaining Timely Pediatric Studies of and Adequate Pediatric Labeling for Human Drugs and Biologics; Advanced Notice of Proposed Rulemaking - 4/24/2002 - (PDF), (Text)

FEDERAL REGISTER Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs; Final Rule - 2/1/2002 - (PDF), (Text)

2001

FEDERAL REGISTER Foreign Establishment Registration and Listing; Final Rule - 11/27/2001 - (PDF), (Text)

FEDERAL REGISTER Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Final Rule - 8/6/2001 - (PDF), (Text)

FEDERAL REGISTER Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents - 6/11/2001 - (PDF), (Text)

FEDERAL REGISTER General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification - 6/11/2001 - (PDF), (Text)

FEDERAL REGISTER Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports; Delay of Effective Date; Final Rule; delay of effective date - 2/20/2001 - (PDF), (Text)
   Final Rule published 10/30/2000

FEDERAL REGISTER Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation; Proposed Rule - 1/18/2001 - (PDF), (Text)

FEDERAL REGISTER Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Confirmation in Part and Technical Amendment - 1/10/2001
(PDF), (Text)

2000

FEDERAL REGISTER Revision to Requirements for Licensed Anti-Human Globulin and Blood Grouping Reagents; Final Rule - 12/12/2000 - (PDF), (Text)

FEDERAL REGISTER Revision to Requirements for Licensed Anti-Human Globulin and Blood Grouping Reagents; Companion to Direct Final Rule - 12/12/2000 - (PDF), (Text)

FEDERAL REGISTER Biological Products: Reporting of Biological Product Deviations in Manufacturing; Final Rule - 11/7/2000 - (PDF), (Text)

FEDERAL REGISTER Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports; Final Rule - 10/30/2000 - (PDF), (Text)

FEDERAL REGISTER Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Technical Amendment; Final Rule - 10/6/2000 - (PDF), (Text)

FEDERAL REGISTER Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License; Technical Amendment; Final Rule - 8/29/2000 - (PDF), (Text)

  • FEDERAL REGISTER Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License; Final Rule - 10/20/1999 - (PDF), (Text)

FEDERAL REGISTER Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human) and Immune Globulin (Human); Final Rule - 8/28/2000 - (PDF), (Text)

FEDERAL REGISTER Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human); Confirmation in Part and Technical Amendment; Final Rule - 3/14/2000 - (PDF), (Text)

FEDERAL REGISTER New Drug Applications; Drug Master Files; Final Rule - 1/12/2000 - (PDF), (Text)

1999

FEDERAL REGISTER Postmarketing Studies for Human Drugs and Licensed Biological Products; Status Reports; Proposed Rule - 12/1/1999 - (PDF), (Text)

FEDERAL REGISTER Human Drugs and Biologics; Determination That Informed Consent Is NOT Feasible or Is Contrary to the Best Interests of Recipients; Revocation of 1990 Interim Final Rule; Establishment of New Interim Final Rule -10/5/1999 - (PDF), (Text)

FEDERAL REGISTER Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents; Proposed Rule - 8/19/1999 - (PDF), (Text)

FEDERAL REGISTER General Requirements for Blood, Blood Components and Blood Derivatives; Notification of Deferred Donors; Proposed Rule - 8/19/1999 - (PDF), (Text)

FEDERAL REGISTER Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Direct Final Rule - 8/19/1999 - (PDF), (Text)

FEDERAL REGISTER Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Companion Document to Direct Final Rule; Proposed Rule - 8/19/1999 - (PDF), (Text)

FEDERAL REGISTER Plasma Derivatives and Other Blood-Derived Products; Requirements for Tracking and Notification; Advance Notice of Proposed Rulemaking - 8/19/1999 - (PDF), (Text)

FEDERAL REGISTER Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring - 5/17/1999 - (PDF), (Text)

FEDERAL REGISTER Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human); Direct Final Rule - 5/14/1999 - (PDF), (Text)

FEDERAL REGISTER Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human); Companion Document to Direct Final Rule; Proposed Rule - 5/14/1999 - (PDF), (Text)

FEDERAL REGISTER Investigational New Drug Applications; Clinical Holds; Direct Final Rule; Confirmation of Effective Date - 4/21/1999 - (PDF), (Text)

1998

FEDERAL REGISTER Investigational New Drug Applications; Clinical Holds; Direct Final Rule - 12/14/1998 - (PDF), (Text)

FEDERAL REGISTER Investigational New Drug Applications; Clinical Holds; Companion Document to Direct Final Rule - 12/14/1998 - (PDF), (Text)

FEDERAL REGISTER Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics and Devices; Final Rule - 11/20/1998 - (PDF), (Text)

FEDERAL REGISTER Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics and Devices; Proposed Rule - 6/8/1998 - (PDF), (Text)

FEDERAL REGISTER Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring; Proposed Rule - 5/22/1998 - (PDF), (Text)

FEDERAL REGISTER Natural Rubber-Containing Medical Devices; User Labeling; Final Rule - 5/6/1998 - (PDF), (Text)

1997 and earlier

FEDERAL REGISTER Biological Products; Reporting of Errors and Accidents in Manufacturing; Proposed Rule - 9/23/1997; Correction 11/3/1997 - (PDF), (Text)

FEDERAL REGISTER Revision of the Requirements for a Responsible Head for Biological Establishments; Final Rule - 10/15/1997 - (PDF), (Text)

FEDERAL REGISTER Expedited Safety Reporting Requirements for Human Drug and Biological Products; Final Rule - 10/7/1997 - (PDF), (Text)

FEDERAL REGISTER Human Tissue Intended for Transplantation; Final Rule - 7/29/1997 - (PDF), (Text)

 
Updated: September 9, 2008