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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

Keeping Track: Tpoxx Wins Green Light For Smallpox, Submissions Galore, And A Broader Approval For Xtandi

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

CMS' Verma Touts Value-Based Payments After Cancellation Of Pilot For Novartis' Kymriah

'It's not for every medication,' CMS administrator says, but agency continues to explore how to apply value-based pricing.

Medicare ImmunoOncology

Gene Therapies Need Long-Term Follow-Up Plan From Outset Or Risk Clinical Hold

Although a sponsor may conclude that a long-term follow-up protocol is not necessary for a gene therapy, FDA may have a different interpretation, and the agency won't let studies start if that's the case, draft gudiance states.
Biologics Safety

US FDA References Off-Label Use In Otherwise Bland Labeling Draft Guidance

Product labels can be required to have warnings related to commonly prescribed unapproved uses with significant safety risks.

Safety FDA

Breakthrough, Priority Review Designations Could Set High-Water Marks In 2018

Announcements of designations for both US FDA's expedited pathway are on torrid paces through first half of 2018. 
Drug Review Review Pathway

US FDA Likely To Shatter Novel Approval Record In 2018

With at least 40 pending novel products, FDA seems poised to break its 2017 approval record of 46, and could even reach 60.

Approvals Drug Review
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