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April 30, 2020

Coronavirus (COVID-19) Update: Daily Roundup April 30, 2020

For Immediate Release: April 30, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
April 30, 2020

Sample formats for Form FDA 356h_2011

Docket Number: FDA-2013-S-0610 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Attachment II Sample Formats— Form FDA 356h for Ammonia N 13 Injection […]
April 30, 2020

Safety Labeling Changes — Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act

Docket Number: FDA-2011-D-0164 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides information on the […]
April 30, 2020

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals

Docket Number: FDA-2009-D-0006 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The purpose of this guidance is […]
April 30, 2020

S8 Immunotoxicity Studies for Human Pharmaceuticals

Docket Number: FDA-2005-D-0022 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The objectives of this guidance are […]
April 30, 2020

S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals

Docket Number: FDA-2004-D-0378 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance describes a nonclinical testing […]
April 30, 2020

S7A Safety Pharmacology Studies for Human Pharmaceuticals

Docket Number: 00D-1407 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance was developed to help […]
April 30, 2020

S6(R1) Addendum: Preclinical Safety Evaluation of Biotechnology

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written […]
April 30, 2020

Changes to an Approved NDA or ANDA: Questions and Answers

Docket Number: FDA-1999-D-0049 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This document provides questions and answers relating to the guidance on Changes […]
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