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MGC Diagnostics Corporation

http://mgcdiagnostics.com/

Latest From MGC Diagnostics Corporation

US FDA Biosimilar Review Information Requests Should Come Earlier, With Longer Response Times

An FDA consultant and industry representatives recommend streamlining information requests during 351(k) application reviews and giving companies more than two days to respond; Eastern Research Group’s final assessment of the BsUFA II program finds positive views, but industry says more transparency is needed on timelines for delayed inspections.

Biosimilars User Fees

US FDA Biosimilar Review Information Requests Should Come Earlier, With Longer Response Times

An FDA consultant and industry representatives recommend streamlining information requests during 351(k) application reviews and giving companies more than two days to respond; Eastern Research Group’s final assessment of the BsUFA II program finds positive views, but industry says more transparency is needed on timelines for delayed inspections.

Biosimilars User Fees

‘A Lot To Consider’ For Sponsors Planning Decentralized Trials

A senior MHRA official tells sponsors not to get "put off" by the many factors they need to examine when deciding on the suitability of decentralized trials, and instead seek early advice from regulators.

United Kingdom Clinical Trials

Sanofi Challenges J&J’s Darzalex With Blackstone Pact For SC Sarclisa

The French major has entered a risk-sharing collaboration with Blackstone focused on a new formulation of multiple myeloma drug Sarclisa, which could help it take on market leader Darzalex.

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Company Information

  • Industry
  • Medical Devices
    • Diagnostic Equipment & Supplies
  • Other Names / Subsidiaries
    • Angeion Corporation
    • MGC Diagnostics Corporation (effective August 21, 2012)
    • MediSoft SA
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