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May 15, 2020

Postapproval Changes to Drug Substances Guidance for Industry

Docket Number: FDA-2018-D-3151 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides recommendations to holders of approved new drug applications (NDAs), abbreviated […]
May 15, 2020

Population Pharmacokinetics

Docket Number: FDA-2019-D-2398 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is intended to assist […]
May 15, 2020

Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products

Submit Comments by 05/31/2020 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
May 15, 2020

Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry

Docket Number: FDA-2018-D-3092 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides recommendations to industry […]
May 15, 2020

Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry

Docket Number: FDA-2016-D-3969 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance outlines the recommended format and content for a sponsor or […]
May 15, 2020

Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance

Docket Number: FDA-2013-D-1444 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance announces FDA’s intention with regard to enforcement of section 503A […]
May 15, 2020

Pharmaceutical Components at Risk for Melamine Contamination

Docket Number: FDA-2009-D-0354 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Drug Evaluation and Research This guidance is intended to alert pharmaceutical manufacturers […]
May 15, 2020

PET Drugs–Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide

Docket Number: FDA-2011-D-0541 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to help small businesses understand and comply with […]
May 15, 2020

PET Drug Products – Current Good Manufacturing Practice (CGMP)

Docket Number: FDA-1998-D-0025 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to help positron emission tomography (PET) drug producers […]
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