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Drugs

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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Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act	Final	Withdrawn 9/2008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 Sample formats for chemistry, manufacturing, and controls sections Sample formats for labeling Sample formats for Form FDA 356h Sample formats for user fee Form FDA 3397	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 Frequently Asked Questions on Pediatric Exclusivity (505A), The Pediatric "Rule," and Their Interaction	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

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