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Medical Devices

Clarius Mobiles Musculoskeletal AI Measurer

FDA clears a Clarius Mobile Health 510(k) for its new MSK (musculoskeletal) AI model, which automatically identifies and measures tendons in the foot,...

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Medical Devices

Xenex Files De Novo for Disinfection Device

Xenex Disinfection Services files a de novo petition for its LightStrike+ ultraviolet room disinfection technology.

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Medical Devices

RightEye Promoting Off-Label Use: FDA

FDA warns Bethesda, MD-based RightEye that it is promoting off-label use of its adulterated and misbranded RightEye Vision System.

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Human Drugs

Multiple Violations at Adept Life Science

FDA warns Chandler, AZ-based Adept Life Science about CGMP and misbranding violations in its production of dietary supplements.

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Human Drugs

GDUFA 2022 Science and Research Report

FDA issues the FY 2022 GDUFA Science and Research Report with information on projects in 13 scientific areas.

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Human Drugs

Improve Biosimilar Development and Approval Efficiency

Two FDAers introduce a journal issue exploring ways in which clinical pharmacology innovations can expand the development and approval of biosimilars.

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Human Drugs

Externally Controlled Trial Guidance

FDA publishes a draft guidance with considerations for designing and conducting externally controlled trials for drug and biological products.

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Human Drugs

FDA 'Defying' Appeals Court is Troubling: Attorneys

Two Epstein Becker attorneys say an FDA statement challenging the 11th Circuit Court of Appeals application of its position on orphan drug exclusivity...

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Biologics

CBER 2023 Guidance Agenda

FDA publishes its 2023 guidance agenda listing 11 guidances it is considering developing this year.

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FDA General

Biden Administration Ending Public Health Emergency 5/11

The Biden Administration announces that it will end the current Covid-19 public health emergency declaration and national emergency declaration, which...