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Respironics Reports 111 Deaths in 3Q 2023: FDA

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Just two days after agreeing to a consent decree, FDA says that Philips Respironics reported over 7,000 medical device reports and...

Guide on Monoclonal Antibodies Docket Correction

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Federal Register notice: FDA corrects a 12/21/2023 notice announcing the availability of a final guidance entitled Development of ...

FDA to Down-classify Many IVDs

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CDRH director Jeffrey Shuren says the Center will propose down-classifying many in vitro diagnostic tests from Class 3 to Class 2 ...

World Cancer Day Treatment Virtual Discussion

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FDA and EMA schedule a 2/1 virtual public discussion on innovative therapies for some cancers to mark World Cancer Day.

Defender Pharma Complete Response on Nausea Drug

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FDA sends Defender Pharmaceuticals a complete response letter on its NDA for intranasal scopolamine (DPI-386) for preventing nause...

Musk Reports Implanting 1st Chip in Human Brain

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Neuralink founder Elon Musk announces the first chip implant in the brain of a human clinical trial participant.

Panel to Discuss Geron Imetelstat NDA

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Federal Register notice: FDA announces a 3/14 Oncologic Drugs Advisory Committee meeting to discuss a Geron NDA for imetelstat for...

Guide on Genome Editing Gene Therapies

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Federal Register notice: FDA makes available a final guidance entitled Human Gene Therapy Products Incorporating Human Genome Edit...

Guide on CAR T Cell Product Development

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Federal Register notice: FDA makes available a final guidance entitled Considerations for the Development of Chimeric Antigen Rece...

Draft Guide on Race/Ethnicity Trial Data

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Federal Register notice: FDA makes available a draft guidance entitled Collection of Race and Ethnicity Data in Clinical Trials an...