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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

Rx Importation: Califf's Switch Means US FDA Commissioners No Longer Uniformly Opposed

In JAMA editorial, former FDA chief supports drug importation under narrow circumstances as a way to reduce drug prices, marking a shift from his previous stance on the issue and that of other past agency heads. Essay, co-authored by former CMS Acting Administrator Andy Slavitt, calls importation "a workaround born of desperation." 

Pricing Debate Drug Safety

US FDA Looks For Advisory Panel's Blessing Of Development Pathway For Monoclonal Antibodies In Rabies PEP

FDA's Division of Antiviral Products proposes a pathway for sponsors to develop monoclonal antibodies designed for rabies post-exposure prophylaxis as an alternative to anti-rabies virus immunoglobulin, but it wants input from an advisory committee before proceeding.

Evenity's Postmarketing Requirement Includes Feasibility Component Familiar To Other Osteoporosis Drugs

Amgen might have to conduct a randomized CV outcomes trial for Evenity if it's possible; a Pink Sheet analysis reveals that feasibility has been a factor in the US FDA's postmarketing requirements and commitments for other osteoporosis drugs as well. 
Post Market Regulation & Studies Orthopedics

Keeping Track: Approval Of First Intranasal Naloxone Copycat Highlights Otherwise Generic Week

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

Keeping Track: NME Approvals For Evenity And Balversa; Non-NME Approvals For Dovato And Keytruda; But An RTF For Fintepla

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

Amgen's Evenity Clears US FDA With Preferred Indication, Black Box Warning

Osteoporosis treatment romosozumab-aqqg indicated for postmenopausal women at high risk for fracture; advisory committee appears to have help persuade FDA that a black box would be sufficient to manage cardiovascular risk rather than a narrower indication.
Approvals Orthopedics
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