FDA Modernization Act of 1997
CBER FDAMA Guidances / Rules / Notices
Because CBER also regulates a number of medical devices, reference is made to the CDRH Guidance pertaining to FDAMA
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Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review - 1/11/2006
Appendix 2 (PDF)
Appendix 3 -
CDER MAPP 6020.3 (PDF),
CBER SOPP 8405
Appendix 4 (PDF)
Guidance for Industry: Developing Medical Imaging Drug and Biological Products - 6/17/2004
- Part 1: Conducting Safety Assessments - (PDF)
- Part 2: Clinical Indications - (PDF)
- Part 3: Design, Analysis, and Interpretation of Clinical Studies - (PDF)
Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Revision 1) - 1/26/2004 - (PDF), (Text)
FEDERAL REGISTER Mercury Compounds in Drugs and Food; List - 8/1/2003 - (PDF), (Text)
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry - 10/3/2002 - (PDF), (Text)
Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds -
10/26/2000
(PDF),
(Text)
Guidance for Industry and FDA Staff: Guidance on Amended Procedures for Advisory Panel Meetings - 7/22/2000
Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products- 3/7/2000 - (PDF)
Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level - 3/7/2000 - (PDF)
FEDERAL REGISTER Postmarketing Studies for Human Drugs and Licensed Biological Products; Status Reports; Proposed Rule - 12/1/99 - (PDF), (Text)
FEDERAL REGISTER Mercury Compounds in Drugs and Food; List and Analysis; Availability - 11/22/1999 - (PDF), (Text)
Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act - 10/8/1999 - (PDF), (Text)
FEDERAL REGISTER Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring - 5/17/99
(PDF),
(Text)
Federal Register Notice: List of Documents Issued by the Food and Drug Adminstration That Apply to Medical Devices Regulated by CBER -
4/26/99 -
(PDF),
(Text)
Refer to CDRH Guidance pertaining to FDAMA
Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products - 2/3/99 - (PDF)
Draft Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products - (12 pages) - 11/30/98 - (PDF)
FEDERAL REGISTER FDA Plan for Statutory Compliance - 11/24/1998 -
(PDF),
(Text)
Correction to plan - Federal Register Notice 12/17/1998 -
(PDF),
(Text)
Guidance for Industry; Advisory Committees: Implementing Section 120 of the Food and Drug Administration Modernization Act of 1997 - 10/30/98
Federal Register Notice: (PDF),
(Text)
Guidance document: (PDF)
Federal Register: Food and Drug Administration Modernization Act of 1997; Allergenic Patch Test Kits; Request for Comments or Data - 10/1/98
(PDF),
(Text)
Guidance for Industry: Implementation of Section 126, Elimination of Certain Labeling Requirements of the Food and Drug Administration Modernization Act of 1997 - 7/21/98
(PDF)
FEDERAL REGISTER - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics and Devices; Proposed Rule -
6/8/98
(PDF),
(Text)
FEDERAL REGISTER Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring; Proposed Rule -
5/22/98
(PDF),
(Text)
List of Drugs for Which Additional Pediatric Information May Produce Health Benefits in the Pediatric Population - 5/20/1998 - (PDF), (Text)
Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products -
5/15/98
(PDF)
Guidance for Industry: Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements -
5/15/98
(PDF)
Guidance for Industry: Classifying Resubmissions in Response to Action Letters -
5/14/98
(PDF)