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Who is Helping Hahn with Communication Efforts?

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FDA commissioner Stephen Hahns controversial remarks exaggerating the efficacy of convalescent plasma touches off a wider examinat...

FDA Panels to Review Reformulated Oxycontin Studies

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Federal Register notice: FDA announces a 9/10 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anes...

Smiths Medical Recalls Medfusion Software

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Smiths Medical recalls specific software versions used with its Medfusion 3500 and 4000 Syringe Pumps because of an error that may...

House E&C Committee Wants Politics Out of Vaccine

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Leaders of the House Energy and Commerce Committee ask FDA commissioner Stephen Hahn what steps he is taking to ensure that scienc...

HCT/Ps Violations at 2 Banco Vida Facilities

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FDA warns Puerto Ricos Banco Vida Corp. about violations involving its umbilical cord blood products.

Wintac Warned on CGMP Inspection Violations

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FDA warns Wintac Limited about CGMP violations in its production of finished drugs at a facility in Bangalore, India.

Hahn has Mea Culpa Moment on Plasma Therapy Data

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FDA commissioner Stephen Hahn walks back his enthusiastic interpretation of data that supported the agencys recent decision to gra...

New Indication Sought for AbbVies Rinvoq

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AbbVie asks FDA to approve a new indication for Rinvoq to treat patients with active ankylosing spondylitis.

Gyroscope Therapeutics Orbit Subretinal Delivery Cleared

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FDA clears a Gyroscope Therapeutics 510(k) for the Orbit Subretinal Delivery System, indicated for microinjection into the subreti...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Banco Vida, Custom Nutraceuticals and Wintac Limited.