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QS, MDR Violations at Mexicos Unomedical Device

[ Price : $8.95]

FDA warns Mexicos Unomedical Device about Quality System and Medical Device Reporting violations in its production of insulin infu...

Abbott Diabetes Care QS Violations

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FDA warns Abbott Diabetes Care about Quality System violations in its production of glucose monitoring systems at a facility in Al...

Repeat CGMP Violations at Kirkman Drug Manufacturing

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FDA warns the Lake Oswego, OR-based Kirkman drug manufacturing facility about repeat CGMP violations in its production of finished...

12 Observations in Baxter Oncology FDA-483

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FDA releases the form FDA-483 with 12 observations from an inspection at the Baxter Oncology drug manufacturing facility in Halle,...

Guide on Device Cybersecurity Released

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FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submi...

Representative Questions Voucher Program Legality

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Rep. Jake Auchincloss calls on FDA to affirm or refute his conclusion that the Commissioners National Priority Voucher program may...

FDA Cautious Stance on CAR-T Cell Therapies for Autoimmune Diseases

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An FDA-authored journal article signals a supportive but cautious regulatory posture toward the development of chimeric antigen re...

Early Alert on Abiomed Impella RP Heart Pumps

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FDA issues an early alert to warn clinicians about a potentially high-risk issue affecting certain Abiomed heart pump devices used...

FDA Officials Personal Legal Actions Trigger Ethics Probe

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HHS Office of Inspector General begins an ethics investigation into FDA deputy chief of staff Samuel Doran and whether he misled t...

Aquestives Epinephrine Film Gets Complete Response

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FDA sends Aquestive Therapeutics a complete response letter for its NDA for Anaphylm, a sublingual epinephrine film for treating T...