-

Drugs

  • Share Share this page

Modernization Act

 Title and Format  Type  Issue Date
Changes to an Approved NDA or ANDA  Final 4/2004
Classifying Resubmissions in Response to Action Letters  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Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act  Final Withdrawn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 (Posted 7/22/2004)
Appendix 2 [PDF]   [Appendices are scanned copies, which will be replaced by final versions]
Final 11/17/1998
Formal Dispute Resolution: Appeals Above the Division Level

Final

 

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

Final

 

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

PET Drug Applications - Content and Format for NDAs and ANDAs

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

9/1999

Posted 7/27/1999

Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act

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      Final 2/15/2006
Standards for Prompt Review of Efficacy Supplements  Final 5/15/1998
Submission of Abbreviated Reports and Synopses in Support of Marketing Applications  Final 8/1998
Submitting and Reviewing Complete Responses to Clinical Holds (Revised)  Final 10/2000
    
-
-
-
-
-