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Integra LifeSciences Ultrasonic Surgical Device Cleared

[ Price : $8.95]

FDA clears an Integra LifeSciences 510(k) for its Cusa Clarity Ultrasonic Surgical Aspirator System for use in neurosurgery for re...

BD Expanded HPV Assay Approved

[ Price : $8.95]

FDA approves a Becton, Dickinson PMA supplement for an expanded version of its BD Onclarity Human Papillomavirus (HPV) Assay.

FDA Preparing for Combined Flu/Covid-19 Tests This Fall

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FDA commissioner Stephen Hahn says the agency is evaluating several different tests that can simultaneously test for both the flu ...

CGMP Deviations at Mexican Signa Facility

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FDA warns Canadas Signa SA de CV about CGMP violations at its Toluca, Mexico, API manufacturing facility.

Centurion Medical Products Kit Issues

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FDA warns Centurion Medical Products about manufacturing and distributing unapproved medical device/drug combination sterile conve...

Meeting on User Fee FDA-Sponsor Communications

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Federal Register notice: FDA announces an 8/11 public meeting entitled Independent Third-Party Assessment of IND FDA-Sponsor Commu...

FDA Panel to Review Mesoblast BLA

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Federal Register notice: FDA announces an 8/13 Oncologic Drugs Advisory Committee meeting to review a Mesoblast BLA for Remestemce...

Pieris Pharma Study of Cancer Drug on Hold

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FDA places a Pieris Pharmaceuticals Phase 1 study of cancer drug PRS-343 on partial clinical hold while the company conducts an ad...

FDA Withdraws Approval of 10 ANDAs

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Federal Register notice: FDA withdraws approval of 10 ANDAs from multiple applicants after they notified the agency that the drug ...

Draft Guide on Appealing Mammography Actions

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Federal Register notice: FDA makes available a draft guidance entitled Appeal Options Available to Mammography Facilities Concerni...