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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

Shutdown Bite Tightens At US FDA, But Gene Therapy To Get 50 More Reviewers

FDA continues to emphasize the routine and the positive, even though strains on staff and sponsors increase as shutdown grinds on. CBER's new clinical reviewers would oversee the clinical investigation, development and review of cell and gene therapies, although a timeline on the hiring is unclear.

Biologics Regenerative Medicine

Amgen's Evenity Faces CV Safety Gauntlet At US FDA Advisory Cmte.

Narrower indication and a boxed warning for Amgen's osteoporosis drug romosozumab might be sufficient to permit approval.  
Advisory Committees Drug Safety

Keeping Track: A Week Of Calm As Shutdown Drags On

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

Democrats’ Drug Pricing Bills Echo Trump Ideas But Broad Republican Support Unlikely

Upcoming House Oversight Committee hearing on drug pricing offers a chance for fireworks, but broader prospects for new Democratic pricing legislation seem limited.
Legislation Medicare

Drug Safety Announcement Blitz Highlights Gottlieb's PR Savvy As Shutdown Drags On

Release of several different safety announcements showcases US FDA Commissioner Gottlieb's efforts to quell potential public concerns with an active communication strategy. 
Drug Safety Post Market Regulation & Studies

2018 Complete Response Letters: Efficacy Issues Drove Most Product Rejections

US FDA issued at least seven rejections to novel products; opioid analgesic sponsors had very little success, while biosimilar developers had a so-so year.

Complete Response Letters Drug Review
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