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April 15, 2020

Development and Submission of Near Infrared Analytical Procedures

Docket Number: FDA-2015-D-0868 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides recommendations to applicants […]
April 15, 2020

Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease

Docket Number: FDA-2017-D-6617 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 15, 2020

Qualification of Biomarker — Galactomannan in studies of treatments of invasive

Docket Number: FDA-2013-D-1630 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance represents the Food and […]
April 15, 2020

Q8, Q9, and Q10 Questions and Answers

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, Center for Biologics […]
April 15, 2020

Q8, Q9, & Q10 Questions and Answers — Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider)

  I. INTRODUCTION [2] The ICH Quality Implementation Working Group (Q-IWG) has prepared this Points to Consider document covering topics relevant to the implementation of ICH Q8(R2), Q9, and […]
April 14, 2020

Q8(R2) Pharmaceutical Development

Docket Number: FDA-2005-D-0154 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 14, 2020

Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

Docket Number: FDA-1998-D-0003 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 14, 2020

Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

Docket Number: FDA-1997-D-0005 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 14, 2020

Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process

Docket Number: FDA-2004-D-0440 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
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