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U.S. FDA weekly update (WC 03 Jun)

Importing H5 Avian Influenza Samples On June 6, the Federal Select Agent Program announced a new H5 Avian Influenza Virus Exemption. The Administrator of the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) has utilized his exemption authority under 9 C.F.R. 121.5(f) in the select agent and toxin regulations to temporarily exempt H5 avian influenza viruses…
Tehelj
June 12, 2024
May 29, 2024 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 20 May)

FDA Webinar: Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances The U.S. Food and Drug Administration (FDA) is announcing a webinar to discuss draft guidances: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564,when finalized, will describe the FDA’s enforcement policy for certain laboratory…
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May 1, 2024 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 29 Apr)

FDA Takes Action to Help Ensure the Safety and Effectiveness of Laboratory Developed Tests Page Summary: On 29 April, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised…
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January 31, 2024 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 22 Jan)

Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) Page Summary: On January 26, 2024, the FDA held the second in a series of medical device sterilization town halls to: Describe the FDA’s early actions to help assure sterilization capacity in the U.S. and recent activities to reduce overall EtO reliance while maintaining…
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January 24, 2024 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 15 Jan)

FDA and CMS issue joint statement on LDTs Laboratory developed tests, or LDTs, help physicians make critical decisions about their patients’ care. According to the Center for Disease Control and Prevention (CDC), approximately 70% of health care decisions depend on laboratory test results. Because of the important role of laboratory tests in health care decisions, it is essential to ensure…
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January 3, 2024 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive

FDA publishes a new draft guidance on 510(k) Third Party Review Program

The US FDA have published 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations This draft guidance outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by…
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