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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

Insys' Sublingual Buprenorphine Spray Fails At US FDA Panel, But Some Members See Future In Limited Role

Main concerns involved the delayed onset to meaningful pain relief and the safety signal of hypoxia. 
Advisory Committees Neurology

Insys May Need Convenience Argument To Save Sublingual Buprenorphine Spray

US FDA advisory committee will hear agency's concerns with Buvaya's effectiveness, safety, and abuse potential. 
Advisory Committees Neurology

Keeping Track: A Diverse Array Of Approvals, A CRL For Evolus' Botox Competitor, And Coherus Refiles Neulasta Biosimilar

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

REMS Abuse Website: Celgene, Actelion Top List Of Suspected 'Gamers'

Other sponsors could be using tactics other than REMS abuse to game the system, US FDA Commissioner Scott Gottlieb says.

Generic Drugs Risk Management

Antibiotic Test Case: Will LPAD + Non-Inferiority = Approval For Plazominicin's BSI Indication?

 US FDA Office of Antimicrobial Products Director Ed Cox explained to an advisory committee why a non-inferiority analysis could work in the context of an unmet need. 

Advisory Committees Infectious Diseases

REMS Website Will Name, Not Shame, Potential Abusers – Gottlieb

US FDA will list number of inquiries about acquiring samples for generic drug development, and also whether FDA sends letters to brand companies telling them it is safe to provide the generic sponsor with the samples. 
Risk Management Generic Drugs
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