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FDA grants breakthrough device designation to deepull’s BSI test
The US Food and Drug Administration (FDA) has granted breakthrough device designation to deepull’s UllCORE bloodstream ...
JD Supra7h
CDRH Announces Pilot Program to Improve Recall Communication
On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot communications program ...
JD Supra7h
FDA Releases Guidance for Voluntary Qualified Importer Program - Food and Beverage Litigation and Regulatory Update
The U.S. Food and Drug Administration (FDA) has released guidance with revisions to the Food Safety Modernization Act Voluntary Qualified ...
Acsh.org13h
Daft FDA Policy is Adding to the Homelessness Crisis. Here's Why
The FDA’s REMS policy, designed to ensure drug safety, is harming individuals with treatment-resistant schizophrenia by ...
Richmond4d
Virginia: Work group says hold off on drug import program
Virginia should see if other states’ plans to import lower-cost medications from Canada work before asking for federal ...
Regulatory Setback For Applied Therapeutics' Lead Program, FDA Highlights Deficiencies In Clinical Application
FDA rejected Applied Therapeutics' Govorestat for galactosemia, citing NDA deficiencies. The company plans discussions for ...
MedPage Today2d
Florida's Canadian Drug Import Plan Goes Nowhere After FDA Approval
Colorado and Florida are among at least nine states that have passed laws allowing for Canadian drug importation. Colorado's ...