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Reading the Tea Leaves in FDA's AI-Enabled Device Guidelines
While recent draft guidance from the Food and Drug Administration pertaining to artificial intelligence-enable medical ...
JD Supra2d
Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical ...
FDA Recognizes Newly Revised AAMI Sterilization, Ethylene Oxide Guidance
The new entry to FDA’s database of Recognized Consensus Standards is AAMI TIR106:2024: Microbiological methods—Understanding and use of product bioburden data. Three of AAMI’s most notable ...
MPR3d
FDA Unveils Transparency Tool for Easy Check of Contaminant Levels in Foods
HealthDay News — The US Food and Drug Administration has launched the Chemical Contaminants Transparency Tool (CCT Tool), an online searchable database to evaluate potential health risks of ...
RFK Jr. Wants to Close a Controversial FDA Loophole in Food Additive Regulation
The FDA’s GRAS rule lets companies decide if food additives are safe—without agency oversight. RFK Jr. now aims to close this ...
Healio7d
FDA launches online database for chemical containment levels in food
The FDA unveiled the Chemical Contaminants Transparency Tool, a searchable online database that provides a list of chemical ...
JD Supra11h
Makary Is Confirmed as Commissioner of an FDA in Transition
Dr. Martin Makary has been confirmed by the Senate as the next commissioner of the Food and Drug Administration (FDA). Dr. Makary is taking the ...
Tonix Pharmaceuticals Shares Jump After FDA Guidance for TNX-102
The FDA previously granted Fast Track designation to TNX-102 SL for the management of fibromyalgia in 2024, a designation intended to expedite FDA review of important new drugs to treat serious ...
Pleco Therapeutics Announces Positive Outcome of Pre-IND meeting with FDA for PTX-252 in Acute Myeloid Leukaemia
Pleco Therapeutics, a clinical-stage biopharmaceutical company developing novel therapies for difficult-to-treat cancers, ...
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FDA Recognizes Newly Revised AAMI Sterilization, Ethylene Oxide Guidance
All four guidance documents can be found on AAMI ARRAY. Questions about what these FDA approvals mean for AAMI or about the changes to the guidance documents discussed above? Contact the AAMI ...