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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

Orphan Drug Development: Could We Be Seeing The End Of P Values?

Panel of experts stresses need to move toward innovative approaches for rare disease drug development such as Bayesian methods, but this would require a paradigm shift in US FDA's regulatory structure. 
Clinical Trials Rare Diseases

Drug Safety: Sequential Surveillance Helps Regulatory Decision-Making, But Hurt By Premature Specification

US FDA and academic researchers say unknowns related to certain product aspects make it difficult to form a hypothesis in formal sequential surveillance designs.
Drug Safety Post Market Regulation & Studies

Keeping Track: A Burst Of Breakthroughs, A Priority Review For Keytruda, And Some Supplemental Submissions

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

US FDA's Cancer Review Staff Should All Move To Oncology Center of Excellence, Advocates Say

CDER's OHOP, as well as relevant CBER and CDRH staff, should be folded into OCE, which should have final sign-off on all oncology products, ASCO and Friends of Cancer Research say.

Drug Review Cancer

Refining A Controversial Endpoint: Sarepta Banking On Dystrophin Levels For Golodirsen Approval In DMD

While glodirsen did show higher levels of dystrophin production than eteplirsen did, increase is still unlikely to satisfy US FDA reviewers who disagreed with Janet Woodcock's decision to grant accelerated approval to eteplirsen.
Drug Approval Standards Drug Review

Keeping Track: FDA Approves Novel HIV Treatment, New Dosing Regimen For Opdivo; Another Rare Pediatric Disease Designation For Prometic

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

Drug Review Regulation
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