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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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Keeping Track: FDA OKs AMAG's Vyleesi, But Bronchitol And Quizartinib Draw CRLs

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

US FDA Performance Tracker Approvals

Pink Sheet Podcast: New Opioid Approval Standards, Drug Pricing Legislation And New Paragraph IV Data

Our take on the US FDA's new draft guidance on risk/benefit analysis of opioids, a new version of Senate drug pricing legislation and new FDA data on paragraph IV certifications.
Drug Review Legislation

Pink Sheet Podcast: Insys Divests Opioids, Pretomanid's Advisory Committee Meeting, And Biosimilar User Fee Collections

Our discussion of the Insys corporate integrity agreement and bankruptcy filling, US FDA's advisory committee meeting on the TB treatment pretomanid, and new data showing lower US biosimilar user fee collections than expected.
Biosimilars Advisory Committees

USP Rivalry With US FDA Over Compendial Standards Provision Busts Into Open Legislative Fight

In a letter to Senate HELP Committee chairman Sen. Lamar Alexander and ranking member Sen. Patty Murray, USP and other stakeholders are calling for the removal of language that would exclude biological products from requirements to follow USP quality standards.

Biologics Legislation

A Tale Of Two Advisory Panels: The Divergent Fates Of Pretomanid And Plazomicin

The TB Alliance and Achaogen both presented their drugs to US FDA's Antimicrobial Drugs Advisory Committee with small patient populations in pivotal trials. Why did one fare better than the other?
Advisory Committees Infectious Diseases

Keeping Track: First RMAT Approval On The Horizon; Big Weeks For Merck, Lilly And Celgene

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