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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

US FDA Staff Slams Agency Hiring Policies In Report Ahead Of Public Meeting

Agency to discuss results of report, as well as pending 2018 pilot project designed to modernize its hiring practices.

FDA Leadership

AAM, PhRMA Renew Rivalry In Hatch-Waxman Public Comments

Generic association advocates enforcement action against companies that use REMS to block generics while PhRMA disputes claims of REMS abuse and citizen petition delay tactics.

Generic Drugs FDA

Stakeholders Offer Some Hatch-Waxman Creativity, Highlight Limits Of FDA Action

Other proposals were broad in nature, and did not provide the agency with specific mechanisms to consider.

Generic Drugs FDA

Keeping Track: A Second Straight Burst Of FDA Approvals

The latest drug approval and development news from our US FDA Performance Tracker.

Performance Tracker Drug Review

Novel Biologics Will Get Suffixes (Or At Least One Did)

US FDA's approval of Ultragenyx's Mepsevii (vestronidase alfa-vjbk) marks first novel biologic with a suffix, but 10 months after release of the naming guidance how – and even how widely – FDA will implement the policy remains uncertain.

Drug Review Biologics

Dual Injection Approvals? A Comparison Of Indivior, Braeburn Buprenorphine Products

US FDA might approve Indivior and Braeburn's injectable buprenorphine products simultaneously; here's a side-by-side look at the advantages and disadvantages of each.

Advisory Committees Drug Review
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