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April 15, 2021

Cipher Pharmaceuticals Inc. – 11/30/2017

Product: Drugs Recipient: Recipient Name Robert D. Tessarolo Recipient Title President and Chief Executive Officer Cipher Pharmaceuticals Inc. 440 Monticello Avenue, Suite 2200Norfolk, VA 23510United States […]
April 14, 2021

Avanthi, Inc. – 09/28/2018

Product: Drugs Recipient: Recipient Name Sameer Late, P.h.D. Recipient Title Director, Regulatory Affairs Avanthi, Inc. 110 Terry DriveNewtown, PA 18940United States Issuing Office: The Office of […]
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 […]
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