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November 8, 2022

Cross Labeling Oncology Drugs in Combination Regimens

Docket Number: FDA-2020-D-2107 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Drug approvals in oncology often build […]
November 8, 2022

FDA alerts health care professionals of risks to patients exposed to xylazine in illicit drugs

[11-8-2022] Health care professionals should be cautious of possible xylazine inclusion in fentanyl, heroin, and other illicit drug overdoses, as naloxone may not be able to […]
November 8, 2022

Omega & Delta Co., Inc. – 636606 – 11/02/2022

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Ruben De Quesada Recipient Title General Manager Omega & Delta Co., Inc. Carr. 887 Km 0 […]
November 8, 2022

The Anthos Group, Inc. – 636846 – 11/03/2022

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Shan Umer Recipient Title President The Anthos Group, Inc. 705 N Douglas StreetEl Segundo, CA 90245United […]
November 8, 2022

Abraxis Bioscience LLC – 633713 – 10/31/2022

Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Mr. Giovanni Caforio Recipient Title Chief Executive Officer Abraxis Bioscience LLC 620 N 51st Ave.Phoenix, […]
November 8, 2022

Sameness Evaluations in an ANDA — Active Ingredients

Submit Comments by 01/08/2023 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
November 7, 2022

Audio Transcript | The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities

Joan: Welcome to the CDER Small Business and Industry Assistance (SBIA) Chronicles Podcast Series. Today’s topic: The FDA Compounding Incidents Program: Adverse Events Associated with Compounded […]
November 7, 2022

Expanded Access | Information for Physicians

On average, FDA determines that the vast majority of all expanded access requests may proceed. Sometimes called “compassionate use”, expanded access is a potential pathway for […]
November 7, 2022

Adam’s Polishes, LLC Issues Voluntary Nationwide Recall of Hand Sanitizer Due to Potential Contamination With Methanol

Summary Company Announcement Date: November 05, 2022 FDA Publish Date: November 07, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of methanol Company […]
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