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Human Drugs

J&J Gets Full Approval for Rybrevant

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

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Medical Devices

CDRH Cautions on Breast Implant Removal

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

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Human Drugs

Antibody-Drug Conjugate Guidance

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

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Human Drugs

Hard for States to Meet Import Rules: Califf

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

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Medical Devices

Electrical OR Table Problems

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

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Human Drugs

Ex-PCA Head Sentenced to 6 Months in Jail

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

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Medical Devices

Wipro GE Healthcare Recalls Incubators

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

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Medical Devices

Animal Lab Issues at Musk Neuralink Site

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

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Federal Register

Info Collection for Device User Fee Forms

Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Fa...

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Federal Register

Info Collection on Device Export Certificates

Federal Register notice: FDA sends to OMB an information collection revision entitled Export Certificates for FDA Regulated Products.