Drugs

Modernization Act

Below is a sortable table of Guidances under the heading Modernization Act:

CategoryTitleTypeDate
Pharmaceutical Quality/CMC Changes to an Approved NDA or ANDA (PDF - 173KB) Final Guidance 04/01/04
Modernization Act; User Fees Classifying Resubmissions in Response to Action Letters. (PDF - 76KB) Final Guidance 05/14/98
Modernization Act Fast Track Drug Development Programs - Designation, Development, and Application Review: Appendix 2 (PDF - 3.9MB) Final Guidance 12/11/92
Modernization Act Formal Dispute Resolution: Appeals Above the Division Level (PDF - 30KB) Final Guidance 02/01/00
Procedural Formal Meetings Between the FDA and Sponsors or Applicants_ (PDF - 69KB) Final Guidance Rev. 1 05/19/09
Modernization Act Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees. (PDF - 62KB) Final Guidance 10/01/98
Modernization Act Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements. (PDF - 979KB) Final Guidance 07/01/98
Modernization Act; Procedural Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions. (PDF - 34KB) Final Guidance 03/01/02
Modernization Act; Procedural Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions-Draft Guidance (PDF - 40KB) Draft Guidance 01/01/04
Modernization Act; Procedural National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs (PDF - 74KB) Final Guidance 04/01/98
Procedural; Modernization Act PET Drug Applications - Content and Format for NDAs and ANDAs_2011 (PDF - 429KB) Final Guidance 08/31/11
Procedural; Modernization Act PET Drug Applications - Content and Format for NDAs and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011 (PDF - 614KB) Final Guidance 08/31/11
Procedural; Modernization Act Sample formats for Form FDA 356h_2011 (PDF - 601KB) Draft Guidance 02/02/11
Positron Emission Tomography (PET) Drug SPL
Modernization Act 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 Guidance 05/07/09
Modernization Act; Procedural Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act (PDF - 85KB) Final Guidance 05/01/98
Modernization Act Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (PDF - 456KB) Final Guidance 02/15/06
Modernization Act Standards for Prompt Review of Efficacy Supplements _Guidance (PDF - 76KB) Final Guidance 05/15/98
Submitting and Reviewing Complete Responses to Clinical Holds (Revised)  (PDF - 26KB)
Clinical/Medical Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. (PDF - 129KB) Final Guidance 05/14/98
Clinical/Medical Submission of Abbreviated Reports and Synopses in Support of Marketing Applications. (PDF - 43KB) Final Guidance 08/01/99

Page Last Updated: 09/01/2015
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