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April 17, 2020

Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry

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 17, 2020

E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs

Docket Number: FDA-2004-D-0241 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 17, 2020

E12A Principles for Clinical Evaluation of New Antihypertensive Drugs

Docket Number: FDA-2000-D-0785 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This document provides general principles for […]
April 17, 2020

E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population

Docket Number: FDA-2016-D-3848 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 17, 2020

Food and Drug Administration Reauthorization Act of 2017 (FDARA) Hiring Data

As part of the reauthorizations of the Prescription Drug User Fee Act (PDUFA VI) and the Biosimilar User Fee Act (BsUFA II), the Food and Drug […]
April 17, 2020

Nova Botanix LTD DBA CanaBD – 606579 – 04/16/2020

Product: Drugs Recipient: Nova Botanix LTD DBA CanaBD International House24 Holborn ViaductLondonEC1A 2BNUnited Kingdom [email protected] Date:               April 16, 2020 RE:                  Unapproved and Misbranded Products Related […]
April 17, 2020

Drug Products, Including Biological Products, that Contain Nanomaterials – Guidance for Industry

Docket Number: FDA-2017-D-0759 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Nanotechnology can be used in a […]
April 17, 2020

Drug Shortages Response | COVID-19

During the Coronavirus Disease 2019 (COVID-19) pandemic, FDA has been closely monitoring the medical product supply chain with the expectation that it may be impacted by the […]
April 17, 2020

Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers

Docket Number: FDA-2016-D-1307 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
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