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Lilly Inspection Cites 8 Findings: Report

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A 7/2023 inspection of Eli Lillys Branchburg, NJ cites eight GMP deficiencies, according to inspection documents referenced in a R...

Globus Recalls Fluoroscopy Fixture Kit

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Globus Medical recalls its ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit due to a calibration error.

Boxed Warning Added to Amgens Prolia

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FDA adds a Boxed Warning to Amgens osteoporosis drug Prolia (denosumab) about increased risk of severe hypocalcemia in patients wi...

Klobuchar Targets Improper Patent Listings

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Senator Amy Klobuchar (D-MN) sends letters to six pharmaceutical companies Abbvie, AstraZeneca, Boehringer Ingelheim, GlaxoSmithK...

FDA OKs Janssens Balversa

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FDA approves a Janssen Biotech NDA for Balversa (erdafitinib) for treating certain adult patients with locally advanced or metasta...

Alvotech Reinspection Lands 1 Observation

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An FDA reinspection of Alvotechs Iceland manufacturing facility results in a Form FDA-483 with one inspection finding.

MRI Labeling for Abbott Neurostimulator

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FDA approves MRI labeling on Abbotts dorsal root ganglion (DRG) stimulation therapy, the Proclaim DRG neurostimulation system.

Novocure PMA Filed for Lung Cancer

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FDA accepts for review a Novocure PMA that seeks approval for the use of tumor treating fields therapy together with standard syst...

FDA, CMS Reiterate Need for FDA Test Oversight

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FDA and CMS officials call for support of an FDA proposal to regulate laboratory-developed tests.

IRB Waiver Info Collection Approved

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Federal Register notice: OMB approves an information collection entitled Institutional Review Board Waiver or Alteration of Inform...