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CGMP, Other Issues at Washington Homeopathic

[ Price : $8.95]

FDA warns Washington Homeopathic Products about CGMP violations in its manufacturing of unapproved new drugs.

Biogen Completes Alzheimers Treatment BLA

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Biogen says it has filed a BLA with FDA for aducanumab to reduce the clinical decline of Alzheimers disease.

Ionogen Selling Unapproved Covid Drug: FDA

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FDA warns Ionogen that its Ionopure Skin & Hands product that the company is marketing to treat Covid-19 is a misbranded unapprove...

FDA Posts Interim Essure Study Results

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FDA releases statistics from an Essure follow-up study showing that patients experienced more issues than those who had laparoscop...

Mylan Recalls 1 Daptomycin Lot

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Mylan recalls one lot of daptomycin for injection, 500 mg/vial, due to particulate matter found in one single-dose vial.

Study of Multiple Indications in DTC Ads

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Federal Register notice: FDA seeks comments on a proposed information collection entitled Study of Multiple Indications in Direct-...

Merck, Eisai Get Complete Response on Combo Therapy

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FDA sends Merck and Eisai a complete response letter on their request for accelerated approval of an NDA for Keytruda (pembrolizum...

CGMP Deviations at Vega Life Sciences

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FDA warns Indias Vega Life Sciences about CGMP deviations in the production of active pharmaceutical ingredients.

Arrow Recalls Intra-Aortic Balloon Pumps

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Arrow International recalls its Arrow AutoCAT 2 Intra-Aortic Balloon Pump and AC3 Optimus Intra-Aortic Balloon Pump Series because...

Reject Covid Vaccine Challenge Trials: Public Citizen

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Public Citizen writes to FDA commissioner Stephen Hahn and three others seeking a declaration that challenge studies will not be a...