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Antibody-Drug Conjugate Guidance

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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...

Info Collection on Device Export Certificates

[ Price : $8.95]

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

Safety Alert on Hintermann Ankle Replacement

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FDA issues safety alert on a higher-than-expected risk of device failure with DT MedTechs Hintermann Series H3 Total Ankle Replace...

Proposed Wound Product Rule Draws Fire

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Three stakeholder organizations raise many questions about and objections to an FDA proposed rule on wound products.