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Wuxi Medical CGMP Violations Found

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FDA warns Chinas Wuxi Medical Instrument Factory about CGMP violations in its manufacturing of finished pharmaceuticals.

Quality System Issues at Preservation Solutions

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FDA warns Preservation Solutions about Quality System violations in its manufacturing of organ transplant preservation solution.

Real World Evidence on Definitions Under Development: Gottlieb

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FDA commissioner Scott Gottlieb says the agency is developing a guidance document on real world evidence (RWE) consensus definitio...

Comments Extended on Hatch-Waxman Act Meeting

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Federal Register notice: FDA extends the comment period for the public meeting on Administering the Hatch-Waxman Amendments: Ensur...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Firson Co., Nova Homeopathic Therapeutics, Preservation Solutions a...

FDA Denies BI Petition to Block GSK Trelegy Ellipta

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FDA approves GlaxoSmithKlines Trelegy Ellipta COPD product and denies a Boehringer Ingelheim petition seeking to impose conditions...

FDA Panel Mixed on Pfizer Expanded Use for Sutent

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FDAs Oncologic Drug Advisory Committee gives a mixed voted on the benefit-risk profile for Pfizers Sutent (sunitinib) as adjuvant ...

FDA Concerns with PD-1/PD-L1 Inhibitors Spread to Roche Studies

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Continuing FDA safety concerns involving PD-1/PD-L1 inhibitors spread to two Roche clinical trials, placing them on partial clinic...

FDA Approves Symbiomix Antibiotic for Vaginosis

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FDA approves a Symbiomix Therapeutics NDA for Solosec (secnidazole) 2g oral granules for treating bacterial vaginosis in adult wom...

Medtronic PMA Approved for Intellis Pain Device

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FDA approves a Medtronic PMA for its Intellis platform for managing certain types of chronic intractable pain.