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Guide on ANDA Pre-Submission Facility Correspondence

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FDA posts a final guidance entitled ANDAs: Pre-Submission Facility Correspondence (PFC) Related to Prioritized Generic Drug Submis...

Senators Introduce Bill to Ban DTC Drug Advertising

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Senators Bernie Sanders (I-VT) and Angus King (I-ME) introduce legislation that would ban direct-to-consumer drug advertising.

Oncologic Panel to Review Multiple Myeloma BLA

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FDA schedules a 7/17 meeting of its Oncologic Drugs Advisory Committee to review and vote on a GSK BLA for Blenrep (belantamab maf...

Medtronic Newport Ventilator Recall Class 1

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FDA says a Medtronic recall of specified Newport ventilators is Class 1.

Questions Raised on New ACIP Members

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The Associated Press reports that questions are being raised about some new members appointed to the CDC Advisory Committee on Imm...

Capricor Gets Form-483 After BLA Facility Inspection

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A recent FDA pre-license inspection of Capricor Therapeutics San Diego manufacturing facility for investigation cell therapy Deram...

FDA Approves UroGen Bladder Cancer Therapy

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FDA approves a UroGen Pharma NDA for Zusduri (mitomycin intravesical solution) for adult patients with recurrent low-grade interme...

Viz.ai Subdural Hemorrhage Quantifier Cleared

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FDA clears a Viz.ai 510(k) for the Viz Subdural Plus, which the company describes as the first and only comprehensive solution for...

Researchers Challenge FDA Lamictal Safety Warning

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Rutgers University researchers say they have determined that the GlaxoSmithKline anti-seizure drug Lamictal is safe for adults wit...

More FDA Operational Changes Coming: Makary

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Saying that operational consolidations are coming in support services, FDA commissioner Martin Makary asks the staff to view chang...