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February 23, 2024

FDA updates on hand sanitizers consumers should not use

Shenzhen Shierjie Biological Engineering Co. Ltd. (China) 75% Alcohol Shierjie 43116-001-0143116-001-0243116-001-0343116-001-04 Shenzhen Shierjie Biological Engineering Co. Ltd. (China) Product manufactured at a facility that did not […]
February 23, 2024

Registered Outsourcing Facilities

AnazaoHealth Corporation, Las Vegas, NV Jaclyn Wong800-995-4363Ext=3120 9/23/2014 12/17/2023 7/29/2022 Yes No Regulatory Meeting Held 5/2/2023 Yes Apocus, Inc., San Antonio, TX Suryanarayana Raju Sagi214-797-7172 10/17/2023 […]
February 23, 2024

Withdrawn | Cancer Accelerated Approvals

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved. Please refer to Drugs@FDA for the latest approvals […]
February 23, 2024

Drug Alerts and Statements

1/29/2024 FDA revises letter of authorization for the emergency use authorization for Paxlovid 1/23/2024 FDA’s ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital […]
February 23, 2024

We Are Hiring

Are you looking for an exciting and rewarding career in the federal government?  Would you like to make a difference in how prescription drugs, including new […]
February 23, 2024

The Brief Summary

The Brief Summary is a quarterly bulletin intended for all Office of Prescription Drug Promotion (OPDP) stakeholders. The Brief Summary provides news and updates related to […]
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