FDA Modernization Act of 1997
CDER-Related Documents

Guidance Documents

1. Changes to an Approved NDA or ANDA [Acrobat] (Issued 11/1999, Posted 11/19/1999)
2. Classifying Resubmissions in Response to Action Letters (Issued 5/14/1998, Posted 5/14/1998)
3. Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act or Word Version (Issued 11/1998, Posted 11/20/1998)
4. Fast Track Drug Development Programs – Designation, Development, and Application Review
   Appendix 2 ;  Appendix 3 consisting of Mapp 6020.3 and SOPP 8405;and Appendix 4 [Appendices are scanned copies, which will be replaced by final versions 11/18] (Issued 11/17/1998, Posted 11/17/1998)
5. FDAMA Section 116 Implementation Information [HTML] or [Acrobat] (Posted 8/13/1999)
6. Formal Dispute Resolution: Appeals Above the Division Level [HTML] or [Acrobat] (Issued 2/2000, Posted 3/6/2000)
7. Formal Meetings With Sponsors and Applicants for PDUFA Products[HTML] or [Acrobat] (Issued 2/2000, Posted 3/6/2000)
8. Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees Wordperfect or Acrobat Version (Issued 10/1998, Posted 11/02/98)
9. Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements (Revised 7/1998, Posted 7/20/98)
10. Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Implementation Plan [HTML] or [PDF] (Issued 6/2001, Posted 6/29/2001)
11. Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank [HTML] or Acrobat (Issued 3/2000, Posted 3/28/2000) 
12. National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs (Issued 4/1998, Posted 5/5/1998)
13. PET Drug Products - Current Good Manufacturing Practice (CGMP) [HTML] or [PDF] (3/29/2002)
14. Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (Issued 5/14/1998, Posted 5/14/1998)
15. Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act [HTML] or [Acrobat] (Issued 9/1999, Posted 10/4/1999)
    • Frequently Asked Questions on Pediatric Exclusivity (505A), The Pediatric "Rule," and Their Interaction (Posted 7/27/1999)
16. Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act (Revised 5/1998, Posted 6/12/1998)
17. Reports on the Status of Postmarketing Studies - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 [HTML] or [PDF] (Posted 4/4/2001)
18. Special Protocol Assessment [HTML] or [PDF] (Issued 5/2002, Posted 5/16/2002)
19. Standards for Prompt Review of Efficacy Supplements (Issued 5/15/1998, Posted 5/15/1998)
20. Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (Issued 8/1998, Posted 9/15/98)
21. Submitting and Reviewing Complete Responses to Clinical Holds (Issued 5/14/1998, Posted 5/14/1998)
22. Women and Minorities Guidance Requirements (Issued 7/20/1998, Posted 11/25/1998)