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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

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

Empagliflozin Likely Needs Another Trial After Rebuke By US FDA Panel

Expanded indication for type 1 diabetes seems out of reach for the moment, but if Boehringer conducts a larger and lengthier trial, it could eventually persuade members of the Endocrinologic and Metabolic Drugs Advisory Committee who voted 14-2 against supplemental approval of empagliflozin for the proposed 2.5mg dose.

Advisory Committees Metabolic Disorders

Gottlieb On Pursuing Legislative Reform: Start Small, Build Later

Former US FDA commissioner Scott Gottlieb encouraged stakeholders at the Association for Accessible Medicine's GRxBiosims 2019 meeting to start small in scope when pushing for legislative changes, which makes it easier to build on later.
Generic Drugs Legislation

Boehringer's Empagliflozin Heads To Advisory Cmte. With Questions On Treatment Effect

Boehringer wants supplemental empagliflozin claim as insulin adjunct to improve glycemic control in type 1 diabetes, but US FDA questions the size of the clinical benefit and the magnitude of a diabetic ketoacidosis risk.

Advisory Committees Metabolic Disorders
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