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Michael Cipriano

Washington, DC
Michael Cipriano is a writer based in Washington, D.C. who covers FDA regulatory policy. He has primarily written about advisory committees, FDA public meetings and drug regulation. He is also part of the Pink Sheet’s efforts to expand coverage into Latin America. Previously, Michael has covered generic drug and biosimilar regulation, as well as issues impacting clinical trials.
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Latest From Michael Cipriano

Keeping Track: An Approval For Ajovy, A CRL For Ruconest, And Some Submissions from J&J

The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA Performance Tracker Drug Review

Biosimilar Leaders Compliment Pfizer For Calling Out Fellow Innovators, But Should FDA Play A Role To Dispel Misinformation?

Industry speakers at AAM's GRx and Biosims conference discussed whether FDA should play a role, or whether education should fall solely on the shoulders of sponsors.
Biosimilars FDA

Opioid REMS Increases Nearly Six-Fold As US FDA Adds Immediate-Release Products

Basically every doctor prescribing any opioid is now covered by the REMS, but training remains voluntary. 
Risk Management Neurology

Biosimilar Sponsors: We Need To Do A Better Job Educating Physicians And Patients

Mylan's Chrys Kokino says failure of sponsors to educate "really is a huge miss on our part."
Biosimilars Regulation

Keeping Track: AstraZeneca Wins Approval For Lumoxiti, AbbVie Expands Label For Venclexta With MRD Data, and FDA Delays Acorda's Inbrijia NDA

The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA Performance Tracker Drug Review

Woodcock Hopes I-SPY 2 Trial Is 'Blazing The Trail' For Future Adaptive Design Uptake

CDER director renews US FDA's support for complex trials, but acknowledges that sponsors are still hesitant to adopt them. 
Clinical Trials Cancer
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