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Teva, Others Try to Resolve Price-Fixing Probe

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Bloomberg News says the federal government and several generic drug companies have been in discussions to resolve an ongoing antit...

Invokana Could Change DKD Treatment: Spherix

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Spherix Global Insights says FDA approval of a new indication for Janssens Type 2 diabetes drug Invokana to slow the progression o...

Vasisht Named Associate Commissioner for Womens Health

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FDA names Kaveeta Visisht to be associate commissioner for womens health.

New FDA Efforts on Device EtO Sterilization

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FDA announces its Ethylene Oxide Sterilization Master File Pilot Program that is intended to allow companies that sterilize single...

FDA Guidances for Generic Drug Developers

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug develo...

Info Collection for Fellowship/Trainee Programs

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Federal Register notice: FDA seeks comments on a proposed information collection for Collection of Information for Participation i...

Guide on Insulin Biosimilar Immunogenicity

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FDA issues a draft guidance on Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.

Renovia Next-Gen Leva Pelvic Therapeutic Cleared

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FDA clears a Renovia 510(k) for its next-generation Leva Pelvic Digital Therapeutic for strengthening pelvic floor muscles and tre...

Complete Response on Adamis High-Dose Naloxone

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FDA issues Adamis Pharmaceuticals a complete response letter on its NDA for Adamis ZimHi (naloxone) high-dose injection for treati...

OPDP Hits Triferic Web Page Promotion

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CDER Office of Prescription Drug Promotion sends Rockwell Medical an untitled letter after reviewing the companys Triferic Web pag...