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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.

Info Collection on Data Monitoring Committees

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Federal Register notice: FDA sends to OMB an information collection extension entitled Establishment and Operation of Clinical Tri...

Vaccines Advisory Committee Meeting 9/30

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Federal Register notice: FDA announces a 9/30 Vaccines and Related Biological Products Advisory Committee meeting.

Class 1 Recall of Alaris Infusion Pump Bezel Assembly

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FDA classifies as Class 1 a Bio-Medical Equipment Service Co. recall of the Alaris Infusion Pump Module Model 8100 pump bezel asse...

PhRMA Updates Healthcare Professional Interaction Code

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Two Hyman, Phelps & McNamara attorneys describe updates to the PhRMA Code on Interactions with Healthcare Professionals dealing wi...