Common Technical Document (CTD) Guidances
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Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document - 7/2/2007
International Conference on Harmonisation (ICH); Guidance for Industry: Granularity Document Annex to M4: Organization of the CTD - 10/18/2005
International Conference on Harmonisation (ICH) Guidance for Industry: M2: eCTD Specification; Questions & Answers and Change Requests - 3/11/2005
International Conference on Harmonisation (ICH); Guidance for Industry: M-4: CTD -- Efficacy: Questions and Answers (Revision 3) - 12/22/2004
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD -- General: Questions and Answers (Revision 3) - 12/22/2004
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD -- Quality: Questions and Answers/Location Issues - 6/8/2004
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD -- Safety: Questions and Answers - 2/3/2003
International Conference on Harmonisation (ICH); Guidance on M4 Common Technical Document - 10/16/2001
Draft Guidance for Industry: Submitting Marketing Applications According to the ICH-CTD Format - General Considerations - 9/5/2001
Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h "Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use" - 5/10/1999
International Conference on Harmonsation (ICH); M4 Common Technical Document: Modules IIA, IIB Nonclinical; Module III, Quality; Modules IV, Nonclinical; Module V, Efficacy - 2/10/2000
Guidance for Industry On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test - 4/23/1999
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product - 3/8/1999
Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products - 2/17/1999
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product - 1/5/1999
Guidance For the Submission of Chemistry, Manufacturing and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products - 1/10/1997
Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use - 8/1996
