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Ex-Pharma Execs Arrested in Racketeering Scheme

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Feds arrest several former pharmaceutical executives and managers at Insys Therapeutics on charges that they led a nationwide cons...

ProNova Gains FDA Clearance for Proton Therapy

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ProNova Solutions receives FDA 510(k) clearance for its SC360 proton therapy system, a compact 360-degree pencil beam scanning pro...

Docket Opened for Drug Review Assessment Under PDUFA

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Federal Register Notice: FDA creates a docket to obtain comments on the final assessment of the Program for Enhanced Review Transp...

FDA Denies Petition Seeking Optimal Naloxone Dose

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FDA denies a citizen petition from Adapt, the manufacturer of Narcan (naloxone) Nasal Spray, asking that it publish a guidance for...

FDA Accepts AstraZeneca BLA for Bladder Cancer Therapy

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FDA accepts for priority review an AstraZeneca BLA for durvalumab, a PD-L1 human monoclonal antibody for treating patients with lo...

FDA Officials Leery About Real World Evidence Potential

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FDA officials examine real world evidence and its potential to contribute efficiently to current knowledge gained from traditional...

Supply Chain Suspect Product Guidance Out

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FDA issues a guidance to help trading partners identify a suspect product and notify FDA and other trading partners.

FDA Clears Exact Imaging Micro-Ultrasound System

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FDA clears an Exact Imaging 510(k) for its ExactVu micro-ultrasound system for urological procedures.

Support for Multi-Region Trial Guidelines

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Stakeholders voice support for International Conference on Harmonization draft guidelines on multi-region clinical trials and make...

Government Wants SCOTUS Biosim Provision Review

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The acting solicitor general says the Supreme Court should hear appeals by Amgen and Sandoz involving two key related provisions o...