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October 13, 2022

Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton Due to Vial Breakage

Summary Company Announcement Date: October 12, 2022 FDA Publish Date: October 13, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Vial Breakage Company Name: […]
October 13, 2022

Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA

Docket Number: FDA-2016-D-0973 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This final guidance is intended to […]
October 13, 2022

Distributed Manufacturing and Point-of-Care Manufacturing of Drugs | Discussion Paper

The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) has issued a discussion paper, Distributed Manufacturing and Point-of-Care Manufacturing of Drugs. […]
October 13, 2022

CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative

Recent FRAME Updates Advanced manufacturing technologies have the potential to improve the reliability and robustness of the manufacturing process and supply chain and increase timely access […]
October 12, 2022

FDA Announces Shortage of Adderall

On October 12, 2022, FDA posted a shortage of the immediate release formulation of amphetamine mixed salts, commonly referred to by the brand name Adderall or […]
October 12, 2022

UPDATED INFORMATION: October 17 – 19, 2022: Hearing Announcement involving the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee – 10/17/2022

On This Page Date: October 17 – 19, 2022 Day1: Mon, Oct 17 8:00 AM – Day2: Tue, Oct 18 8:00 AM – 4:00 PM ET […]
October 12, 2022

Remarks by FDA Commissioner Robert Califf to Health Connect South – 09/22/2022

Speech by Robert M. Califf, M.D., MACC (Remarks  Thank you, Russ [Lipari]. I’m pleased to join you today for the Health Connect South meeting. I’m just […]
October 11, 2022

Eksa Mills S.A. de C.V. – 634706 – 10/05/2022

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Esteban Sabugo Rivero Recipient Title Director/CEO Eksa Mills S.A. de C.V. E. Parque Industrial Carretera Federal […]
October 11, 2022

Legacy Pharmaceutical Packaging LLC – 633735 – 10/03/2022

Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Mr. Bradley M. Rayner Recipient Title President Legacy Pharmaceutical Packaging LLC 13333 Lakefront DriveEarth City, MO […]
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