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Chemistry, Manufacturing, and Controls (CMC); Modernization Act
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Changes to an Approved NDA or ANDA (PDF - 173KB)
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Final Guidance
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04/01/04
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Modernization Act; User Fees
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Classifying Resubmissions in Response to Action Letters. (PDF - 76KB)
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Final Guidance
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05/14/98
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Modernization Act
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Fast Track Drug Development Programs - Designation, Development, and Application Review. (PDF - 311KB)
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Final Guidance
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07/01/04
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Modernization Act
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Fast Track Drug Development Programs - Designation, Development, and Application Review: Appendix 2 (PDF - 3.9MB)
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Final Guidance
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12/11/92
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Modernization Act
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Formal Dispute Resolution: Appeals Above the Division Level (PDF - 30KB)
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Final Guidance
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02/01/00
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Modernization Act
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Formal Meetings Between the FDA and Sponsors or Applicants_PRA (PDF - 95KB)
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Final Guidance
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05/19/09
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Modernization Act
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Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees. (PDF - 62KB)
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Final Guidance
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10/01/98
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Modernization Act
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Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements. (PDF - 979KB)
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Final Guidance
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07/01/98
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Modernization Act
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Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions. (PDF - 34KB)
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Final Guidance
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03/01/02
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Modernization Act
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Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions-Draft Guidance (PDF - 40KB)
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Draft Guidance
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01/01/04
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Modernization Act; Procedural
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National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs (PDF - 74KB)
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Final Guidance
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04/01/98
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Procedural; Modernization Act
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PET Drug Applications - Content and Format for NDAs and ANDAs_2011 (PDF - 429KB)
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Final Guidance
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08/31/11
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Procedural Modernization Act
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PET Drug Applications - Content and Format for NDAs and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011 (PDF - 614KB)
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Final Guidance
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08/31/11
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Procedural; Modernization Act
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Sample formats for Form FDA 356h_2011 (PDF - 601KB)
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Draft Guidance
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02/02/11
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Positron Emission Tomography (PET) Drug SPL
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Modernization Act; Procedural
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Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act _Guidance (PDF - 57KB)
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Final Guidance
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09/01/99
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Modernization Act
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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
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Final Guidance
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05/07/09
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Modernization Act; Procedural
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Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act (PDF - 85KB)
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Final Guidance
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05/01/98
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Modernization Act
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Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (PDF - 456KB)
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Final Guidance
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02/15/06
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Modernization Act
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Standards for Prompt Review of Efficacy Supplements _Guidance (PDF - 76KB)
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Final Guidance
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05/15/98
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Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB)
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Clinical/Medical
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Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. (PDF - 129KB)
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Final Guidance
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05/14/98
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Clinical/Medical
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Submission of Abbreviated Reports and Synopses in Support of Marketing Applications. (PDF - 43KB)
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Final Guidance
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08/01/99
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