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April 14, 2021

Amherst Pharmaceuticals, LLC/Magna Pharmaceuticals, Inc. – 04/24/2019

Delivery Method: TRANSMITTED BY FACSIMILE Product: Drugs Recipient: Recipient Name Warren P. Lesser, DBA, MBA Recipient Title President/CEO Amherst Pharmaceuticals, LLC/Magna Pharmaceuticals, Inc. 10801 Electron Drive, […]
April 14, 2021

Trinity Natural Health & Pain Management, Inc. – 614007 – 04/13/2021

Product: Drugs Recipient: Trinity Natural Health & Pain Management, Inc. 1100 NE 125th Street, Suite #203ANorth Miami, FL 33161United States [email protected] RE: Unapproved and Misbranded Products […]
April 14, 2021

FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19

For Immediate Release: April 14, 2021 The following quote is attributed to Acting FDA Commissioner Janet Woodcock, M.D. During this worldwide public health emergency, the FDA […]
April 14, 2021

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry

Docket Number: FDA-2020-D-1136 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Biologics Evaluation and Research Center for Drug Evaluation and Research FDA plays […]
April 14, 2021

FDA/CDER and AASLD 2021 DILI Conference XVIII – 04/20/2021 – 04/22/2021

On This Page Date: April 20 – 22, 2021 Day1: Tue, Apr 20 9:00 AM – 4:00 PM ET Day2: Thu, Apr 22 9:00 AM – […]
April 13, 2021

FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer

On April 13, 2021, the Food and Drug Administration granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with locally advanced or metastatic urothelial […]
April 13, 2021

La FDA advierte que el abuso y el uso indebido del descongestionante nasal propilhexedrina causan graves daños

En respuesta a los crecientes reportes de abuso y uso indebido de propilhexedrina, analizamos varias fuentes de datos. Estas incluyen las llamadas a los centros de […]
April 13, 2021

Coronavirus (COVID-19) Update: April 13, 2021

Boilerplate The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of […]
April 13, 2021

Mifeprex (mifepristone) Information

Mifeprex is used, together with another medication called misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000. In 2016, the agency approved […]
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