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Liebel-Flarsheim CGMP Violations Cited

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FDA warns Liebel-Flarsheim in Raleigh, NC, about CGMP violations in its production of finished drugs.

Alembic Pharmaceuticals FDA-483 Out

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FDA releases the form FDA-483 with four observations from an inspection at the Alembic Pharmaceuticals active pharmaceutical ingre...

HR Complaints Filed Against Prasad: Report

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A STAT report highlighted in Medpage says CBER employees are concerned about the environment established by their new director, Vi...

FDA Rejects Biohavens Troriluzole Application

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FDA issues Biohaven a complete response letter, rejecting the companys NDA for Vyglxia (troriluzole) as a treatment for spinocereb...

Can Industry Accept a Dysfunctional FDA?: Axios

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An Axios report following the resignation of CDER director George Tidmarsh questions how much more agency dysfunction industry can...

Sarepta Completes Confirmatory Duchenne Trial

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Sarepta Therapeutics reports mixed data from its Phase 3 ESSENCE confirmatory study evaluating its Duchenne muscular dystrophy dru...

Compass Pathways Speeds COMP360 Launch

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Compass Pathways says it expects to be able to launch its COMP360 psilocybin treatment for treatment-resistant depression nine to ...

Otsuka ICU Recalls Mislabeled Potassium Chloride Injection

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Otsuka ICU Medical recalls (Class 1) one lot of its potassium chloride injection, 20 mEq, after discovering that the overwrap labe...

FDA OKs Aqua Medical IDE for Endoscopic Technology Trial

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FDA gives investigative device exemption approval for an Aqua Medical pilot clinical trial of its Proximal Intestinal Mucosal Abla...

Reforms Needed to Boost Efficiency of Global Cancer Trials: Report

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A new report from the Reagan-Udall Foundation calls for broad operational and policy reforms to improve the efficiency, representa...