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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...

FDA Expands Use of Abiomeds Impella CP Heart Pump

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FDA expands approval for an Abiomed PMA for the Impella CP heart pump and its use in high-risk percutaneous coronary interventions...

Gilead Submits NDA for Triple Drug Combo for Hep C

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Gilead Sciences files an NDA for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 10...

Cures Act Device Provisions Explained

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Two Hyman, Phelps attorneys outline key medical device provisions in the 21st Century Cures Act that has overwhelmingly passed the...

Former Deputy Commissioner Gottlieb Added to FDA Short List

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President-elect Donald Trumps transition team reportedly adds former FDA deputy commissioner Scott Gottlieb to the short list of c...

BMS Pays $19.5 Million to Settle Abilify Off-label Charges

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Bristol-Myers Squibb enters into a $19.5 million settlement agreement with 43 states to resolve allegations the company used false...