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Linghai ZhanWang Records Show CGMP Violations

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FDA warns Chinas Linghai ZhanWang Biotechnology Co. about CGMP violations in its manufacturing of over-the-counter drugs.

Positive Data on Pfizer/Arvinas Breast Cancer Study

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Pfizer and Arvinas announce positive topline results from a clinical trial evaluating vepdegestrant monotherapy versus fulvestrant...

FDA Rejects All Mid-Link Technology Data

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FDA tells Chinas Mid-Link Technology Testing Co. it is rejecting all data from all studies conducted by the company until it provi...

Clinical Researchers Plead Guilty to Fraud

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Two clinical research facility owners plead guilty in Florida federal court to conspiracy to commit wire fraud in connection with ...

FDA Warns 6 Firms on Unapproved Fat-Dissolving Drugs

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FDA warns six companies that they are marketing unapproved fat-dissolving drugs.

Sydnexis NDA Accepted for Pediatric Myopia

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FDA accepts a Sydnexis NDA for SYD-101 (topical low-dose atropine) for treating progression of pediatric myopia.dr

Beckman Coulter 510(k) Cleared for Clinical Analyzer

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FDA clears a Beckman Coulter Diagnostics 510(k) for its DxC 500i Clinical Analyzer.

Top Device Science Official Leaves FDA

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CDRH chief scientist and deputy Center director Doug Kelly abruptly resigns after less than five years at the agency.

Glenmark Pharma Hit With 483 After India Inspection

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FDA belatedly inspects Indias Glenmark Pharmaceuticals after a recent ProPublica investigative report found that the agency hadnt ...

FDA Taps Jim Traficant as Chief of Staff

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FDA names former business consultant Jim Traficant as chief of staff where he will oversee and lead the agencys major initiatives....