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CDRH Announces Organizational Changes

[ Price : $8.95]

CDRH announces new organizational changes to help it meet commitments under the Medical Device User Fee Amendments reauthorization...

Baxter Recalls Life200 Ventilators

[ Price : $8.95]

Baxter recalls its Life200 Ventilator System due to the potential for battery failure involving its charging dongle.

Lonza Swiss Facility Gets FDA-483

[ Price : $8.95]

FDA issues a one-item 483 after inspecting a Lonza Visp, Switzerland manufacturing facility.

Gottlieb Calls for Congress Help with AI Device Regulation

[ Price : $8.95]

Former FDA commissioner Scott Gottlieb says Congress needs to design a framework for the modern, efficient regulation of medical a...

Indivior Pulls Plug on Schizophrenia Drug Marketing

[ Price : $8.95]

Citing payor management concerns, Indivior says it is discontinuing sales and marketing for schizophrenia drug Perseris (risperido...

Bausch+Lomb Recalls I-Pack Injection Kit

[ Price : $8.95]

Bausch+Lombs Synergetics unit recalls its I-PACK Injection Kit with Drape, which is used for the administration of an intravitreal...

FDA Withdraws Takeda NDA for Exkivity

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of a Takeda NDA for Exkivity (mobocertinib succinate) capsules after a confirmator...

AskBio Gets Fast Track for Parkinsons Gene Therapy

[ Price : $8.95]

FDA grants Bayer-owned Asklepios BioPharmaceutical a fast track designation for AB-1005, a gene therapy candidate for treating mod...

2 Updated Guides on Dental Resin and Curing Lights

[ Price : $8.95]

Federal Register notice: FDA releases two draft guidances entitled Dental Composite Resin Devices Premarket Notification (510(k))...

Oticon Sentio Hearing Device Cleared

[ Price : $8.95]

FDA clears an Oticon Medical 510(k) for its active transcutaneous bone conduction hearing system, the Sentio System.