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April 21, 2020

Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance

In section VI(C)(2) of the Generic Drug User Fee Amendments Reauthorization for Fiscal Years 2018-2022 (GDUFA II Commitment Letter), FDA committed to publishing quarterly metrics on […]
April 21, 2020

Frequently Asked Questions – Statement of Investigator (Form FDA 1572)

Docket Number: FDA-2008-D-0406 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Office of Clinical Policy, Office of Good Clinical Practice Office of Medical […]
April 21, 2020

Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application*

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guideline describes an acceptable format for organizing and […]
April 21, 2020

Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Biopharmaceutics studies are required by Part 320, Title 21, […]
April 21, 2020

Format and Content of the Clinical and Statistical Sections of an Application

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guideline is intended to assist an applicant in […]
April 21, 2020

January 14, 2020 Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement – 01/14/2020 – 01/14/2020

On This Page Date: January 14, 2020 Time: 8:00 AM – 5:30 PM ET Center Date Time Location CDER January 14, 2020 8:00 a.m. to 5:30 […]
April 21, 2020

Format and Content of a REMS Document Guidance for Industry

Docket Number: FDA-2009-D-0461 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 21, 2020

Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry

Docket Number: FDA-2017-D-6530 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides recommendations to industry […]
April 21, 2020

Food-Effect Bioavailability and Fed Bioequivalence Studies

Docket Number: FDA-2001-D-0040 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides recommendations to sponsors […]
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