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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...

I-Mab Gets Breakthrough for Nephropathy

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FDA grants I-Mab a breakthrough therapy designation for felzartamab, an investigational CD38 antibody for treating primary membran...

FDA Continues Device Supplement Guidance

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FDA says it will continue to exercise enforcement discretion for some supplements to PMAs and HDEs.

FDA OKs Keytruda in Biliary Tract Cancer

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FDA approves Mercks Keytruda (pembrolizumab) for use with gemcitabine and cisplatin for locally advanced unresectable or metastati...

Why Are FDA-483 Observations the Same?

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Former FDAer Steve Lynn asks what the drug industry and regulators can do working together to break the cycle of more than 20 year...

FDA Seeks Nonvoting Device Panel Members

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Federal Register notice: FDA selects interested industry organizations to participate in selecting nonvoting industry representati...