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August 2, 2021

2017 Meeting Materials, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee)

2017 Meeting Materials, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee) | FDA In this section: Antimicrobial Drugs Advisory Committee (formerly known […]
August 2, 2021

2018 Meeting Materials, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee)

                                                                           August 8, 2018 Meeting of the Antimicrobial Drugs Advisory Committee August 8, 2018: Antimicrobial Drugs Advisory Committee Meeting Announcement Committee Roster for the August 8, […]
July 30, 2021

FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19

The U.S. Food and Drug Administration today revised the emergency use authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together) authorizing REGEN-COV for emergency use as […]
July 30, 2021

Bershtel Enterprises LLC dba WePackItAll – 570885 – 07/21/2021

Delivery Method: Via Email Delivery Confirmation Product: Drugs Recipient: Recipient Name Natan Bershtel Recipient Title President Bershtel Enterprises LLC dba WePackItAll 2745 Huntington Dr.Duarte, CA 91010United […]
July 30, 2021

Bershtel Enterprises LLC dba WePackItAll – 570885 – 05/02/2019

Delivery Method: VIA SIGNATURE CONFIRMED DELIVE Product: Drugs Pharmaceutical Quality Current Good Manufacturing Practice (CGMP) Recipient: Recipient Name Mr. Jack S. Bershtel Recipient Title Managing Partner […]
July 29, 2021

Frequently Asked Questions | Clozapine REMS Modification

On July 29, 2021, FDA approved modifications to the Clozapine Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the […]
July 29, 2021

MB Solutions, LLC/BioSpectrum CBD – 610649 – 07/22/2021

Delivery Method: Via Email Product: Animal & VeterinaryDrugsFood & Beverages Recipient: Recipient Name Frederic A. Melius, MD MB Solutions, LLC/BioSpectrum CBD 5980 Executive Dr. Suite AMadison, […]
July 29, 2021

Information on Clozapine

Latest Update On July 29, 2021, FDA approved a modification to the Clozapine Risk Evaluation and Mitigation Strategy (REMS). Beginning November 15, 2021 new requirements will […]
July 29, 2021

Clozapine Risk Evaluation and Mitigation Strategy (REMS) requirements will change on November 15, 2021

[Updated 7/29/21] CPMG and FDA continue to work to ensure that patients relying on clozapine have continued access to this medication and appropriate management of associated […]
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