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May 6, 2020

User Fee Waivers, Reductions, and Refunds for Drug and Biological Products

Docket Number: FDA-2011-D-0108 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides recommendations to applicants […]
May 6, 2020

Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments

Docket Number: FDA-2018-D-2544 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance applies to orally administered drug products and provides recommendations to […]
May 6, 2020

Upper Facial Lines: Developing Botulinum Toxin Drug Products

Docket Number: FDA-2014-D-0968 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist sponsors in the clinical […]
May 6, 2020

Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731)

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The guidelines recommended in this document for the studies required to bring a Category III […]
May 6, 2020

Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for Industry

Docket Number: FDA-2018-D-1562 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist sponsors in the clinical […]
May 6, 2020

Uncomplicated Gonorrhea: Developing Drugs for Treatment

Docket Number: FDA-2014-D-0640 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist sponsors in the clinical […]
May 6, 2020

Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry

Docket Number: FDA-2016-D-2319 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist sponsors in the clinical […]
May 6, 2020

Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry

Docket Number: FDA-2019-D-4258 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research A drug master file (DMF) is a voluntary submission to FDA that […]
May 6, 2020

Tropical Disease Priority Review Vouchers

Docket Number: FDA-2008-D-0530 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides information on the […]
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