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April 29, 2020

Electronic Submission of IND Safety Reports Technical Conformance Guide

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This document represents the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on this […]
April 29, 2020

Electronic Source Data in Clinical Investigations

Docket Number: FDA-2010-D-0643 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Devices and Radiological Health Center for Biologics Evaluation and Research […]
April 29, 2020

Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.”

Docket Number: FDA-2013-N-1428 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance explains how facilities that elect to register with FDA as outsourcing facilities are to submit drug product reports, consistent with section […]
April 29, 2020

S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)

Docket Number: FDA-97D-0444 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research International Conference on Harmonisation; Guidance on the Duration of Chronic Toxicity Testing […]
April 29, 2020

E9 Statistical Principles for Clinical Trials

Docket Number: FDA-1997-D-0508 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The efficacy and safety of medicinal […]
April 29, 2020

E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES

Docket Number: FDA-2019-D-3049 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Clinical studies of medical interventions are […]
April 29, 2020

E8 General Considerations for Clinical Trials

Docket Number: FDA-1997-D-0440 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA) is publishing a guidance entitled ‘‘E8 […]
April 29, 2020

E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers

Docket Number: FDA-2009-D-0528 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The ICH guidance E7 Studies in […]
April 29, 2020

E7 Studies in Support of Special Populations: Geriatrics

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research It is important to ensure that clinical testing programs […]
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