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Patient Engagement Panel Renewal

[ Price : $8.95]

Federal Register notice: FDA renews its Patient Engagement Advisory Committee for an additional two years beyond the charter expir...

Harvard Drug Group Recalls Eye Drops

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The Harvard Drug Group recalls all lots of polyvinyl alcohol, 1.4% lubricating eye drops and lubricating tears eye drops (dextran/...

FDA/Moderna Revolving Door Analyzed

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A BMJ investigation looks at the case of two former FDA vaccine officials who now work for Moderna.

Lilly Sees Alzheimers Drug Decision Delay

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Eli Lilly says that an FDA review decision for its experimental Alzheimers drug donanemab has been pushed back to the first quarte...

Clinical e-Thermometer Enforcement Policy

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FDA posts a final guidance entitled Enforcement Policy for Clinical Electronic Thermometers.

Enforcement Guide on PMA/HDE Modifications

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Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Certain Supplements for Approved Pre...

Fix Pulse Oximeter Biases, 25 State AGs Tell FDA

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The attorneys general from 25 states list six things FDA should do immediately to address the concern that pulse oximeters are not...

FDA Seeking Diabetes DHT Info

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CDRH asks for public comments on several questions to help it advance the development of digital health technologies for use in di...

FDA OKs Abbott HPV Diagnostic Test

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FDA approves Abbotts Alinity m molecular human papillomavirus (HPV) diagnostic test.

Monoclonal Antibody Manufacturing Changes Research

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FDA researchers look at manufacturing changes and comparability assessment of FDA-approved monoclonal antibodies and Fc-fusion pro...