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May 4, 2020

Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes

Docket Number: FDA-2004-D-0179 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to inform new drug application (NDA) and abbreviated […]
May 4, 2020

Specification of the Unique Facility Identifier (UFI) System for Drug Establishment

Docket Number: FDA-2013-D-0984 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance specifies the unique facility identifier (UFI) system for registration of […]
May 4, 2020

Special Protocol Assessment Guidance for Industry

Docket Number: FDA-2016-D-1174 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides information on the […]
May 4, 2020

Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products

Docket Number: FDA-2019-D-0297 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]
May 1, 2020

Coronavirus (COVID-19) Update: Daily Roundup May 1, 2020

For Immediate Release: May 01, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
May 1, 2020

¿Jabón antibacteriano? No lo necesita; use agua y un jabón normal

Image English Cuando compra jabones y geles de baño, ¿busca usted los productos que dicen “antibacteriano” en la etiqueta con la esperanza de que mantendrán más […]
May 1, 2020

Antibacterial Soap? You Can Skip It, Use Plain Soap and Water

Image Español When you buy soaps and body washes, do you reach for products labeled “antibacterial” hoping they’ll keep your family safer? Do you think those […]
May 1, 2020

Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment

For Immediate Release: May 01, 2020 Today, the U.S. Food and Drug Administration issued an emergency use authorization for the investigational antiviral drug remdesivir for the […]
May 1, 2020

Antroids.com – 606116 – 04/22/2020

Product: Drugs Issuing Office: Center for Drug Evaluation and Research United States RE:                        Notice of Unlawful Sale of Unapproved and Misbranded Drugs Related to Coronavirus […]
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