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Labeling for AI/Machine Learning Devices Workshop

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FDA announces a 10/14 virtual public workshop on improving transparency of artificial intelligence/machine learning-enabled medica...

Stealth Submits Elamipretide NDA Over FDA Concerns

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Stealth BioTherapeutics says it has acceded to Barth syndrome patient community requests and submitted an NDA for elamipretide des...

10 Accelerated Approval Reforms Evaluated

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Researchers evaluate 10 possible reforms to the FDA accelerated approval pathway.

PD-1/PD-L1 Alternative Dosing Regimen Draft Guidance

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FDA publishes a draft guidance on a pharmacokinetic approach to alternative dosing regimens for PD-1 and PD-L1 drugs.

FDA Warning on Shanghai Dasheng N95 Respirators

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FDA alerts health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufactur...

FDA Approves Mirena IUD Duration of Use sNDA

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FDA has approved a Bayer sNDA extending to seven years the duration of use for the companys Mirena IUD birth control device.

J&J Accumulating Data to Support Booster Vaccine

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Johnson & Johnson says it has data supporting the use of its Covid-19 vaccine as a booster shot for people previously vaccinated w...

EUA for BD Veritor At-Home Covid-19 Test

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FDA issues an emergency use authorization for the BD Veritor at-home Covid-19 rapid antigen test that uses a smartphone camera to ...

CGMP Violations at Natural Beauty Care

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FDA warns Australias Natural Beauty of CGMP issues in its production of OTC drugs.

Moderna Seeks Full Licensure for Covid Vaccine

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Moderna completes a rolling BLA and requests a priority review for the submission seeking full licensure of its Covid-19 vaccine.