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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

Drug Development Questions Dominate Hahn's Confirmation, Despite Talk About E-Cigs

A plurality of the questions from the Senate HELP Committee at Stephen Hahn's confirmation hearing to head the US FDA focused on drug development issues, despite the time lawmakers spent discussing the agency's regulation of e-cigarettes.

FDA Leadership

FDA's Stein Sees Differences On Biosimilar Review

US FDA's Office of New Drugs director Peter Stein explained that different review divisions take different approaches in their regulation of biosimilars, but feels their frameworks will become more unified as they gain experience in reviewing biosimilar programs.

Biosimilars Regulation

US FDA's Stein: 'Cognitive Dissonance' Exists Between Review Divisions In Regulation Of Biosimilars

US FDA's Office of New Drugs director Peter Stein explained that different review divisions take different approaches in their regulation of biosimilars, but feels their frameworks will become more unified as they gain experience in reviewing biosimilar programs.

Biosimilars Drug Approval Standards

Pink Sheet Podcast: The Upcoming US FDA Commissioner Confirmation Hearing, Sublocade Loses Orphan Designation, Project Orbis Politics

Pink Sheet reporters look ahead to Stephen Hahn's Senate confirmation hearing, review the revocation of Indivior's buprenorphine orphan designation and consider Richard Pazdur's comments about external issues affecting Project Orbis.
Leadership Review Pathway

Keeping Track Of Review Designations: BTDs For X4, F2G, And BMS; Another QIDP For Allergan

The latest news about products accepted into US FDA expedited review programs.

US FDA Performance Tracker Research & Development

Keeping Track Of User Fee Decisions And Filings: Adakveo, Brukinsa And Fetroja Mark Massive Week Of Novel Approvals

The latest news on US FDA user fee decisions and submissions to the agency.

US FDA Performance Tracker Approvals
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