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Device Recognized Consensus Standards Updated

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Federal Register: FDA announces a publication containing modifications the agency is making to the list of standards it recognizes...

J&J Gets Full Approval for Rybrevant

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FDA grants full approval to Johnson & Johnsons Rybrevant (amivantamab-vmjw) in combination with chemotherapy for the first-line tr...

CDRH Cautions on Breast Implant Removal

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CDRHs Binita Ashar says a recent journal article on breast implant risk provided useful information for patients and providers abo...

Antibody-Drug Conjugate Guidance

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FDA publishes a guidance to assist in the development of antibody-drug conjugates with a cytotoxic small-molecule drug or payload.

Hard for States to Meet Import Rules: Califf

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FDA commissioner Robert Califf says it is very difficult for states to meet the standards set by Congress for importing drugs from...

Electrical OR Table Problems

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FDA says it has received reports of rare adverse events involving electrical operating room tables.

Ex-PCA Head Sentenced to 6 Months in Jail

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A federal judge sentences former pharmacy compounder Patient Care America (PCA) CEO and president Patrick Smith to six months in p...

Wipro GE Healthcare Recalls Incubators

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Wipro GE Healthcare Private Ltd. recalls its Care Plus and Lullaby Incubators due to the devices bedside panel or porthole not pro...

Animal Lab Issues at Musk Neuralink Site

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Reuters reports that FDA investigators found animal research issues at a Neuralink facility in California.

Info Collection for Device User Fee Forms

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Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Device User Fee Cover Sheet, Form FD...