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Drugs

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Modernization Act

 Title and Format  Type  Issue Date
Changes to an Approved NDA or ANDA (PDF - 108 KB) Final 4/2004
Classifying Resubmissions in Response to Action Letters (PDF - 76 KB) Final 5/14/1998
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act  Final Withdrawn
9/2008
Fast Track Drug Development Programs - Designation, Development, and Application Review (PDF - 311 KB) (Posted 7/22/2004)
Appendix 2 [(PDF - 3930 KB)]   [Appendices are scanned copies, which will be replaced by final versions]		 Final 11/17/1998
Formal Dispute Resolution: Appeals Above the Division Level(PDF - 30 KB)

Final

 

  2/2000
Formal Meetings With Sponsors and Applicants for PDUFA Products (PDF - 89 KB) Final 5/19/2009
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees (PDF - 62 KB)

Final

 

 10/1998
Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements (PDF - 979 KB) Final 7/1998
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions(PDF - 34 KB) Final 3/2002
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF - 40 KB) Draft 1/2004
National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs (PDF - 74 KB)  Final 4/1998

PET Drug Applications - Content and Format for NDAs and ANDAs (PDF - 153 KB)

 Draft 3/7/2000
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (PDF - 129 KB) Final 5/14/1998
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (PDF - 57 KB) Final

9/1999

Posted 7/27/1999
Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act (PDF - 85 KB)

Final

 

 Revised
5/1998
Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (PDF - 456 KB)     Final 2/15/2006
Standards for Prompt Review of Efficacy Supplements (PDF - 76 KB) Final 5/15/1998
Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (PDF - 43 KB)  Final 8/1998
Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26 KB) Final 10/2000
    
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