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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

Opioid-Sparing Regimens Face High Hurdles After US FDA Advisory Cmte.

Panelists felt the phrase "opioid sparing" was too broad, and contended that it is difficult to develop a non-opioid alternative without an opioid as an active comparator. 
Advisory Committees Neurology

Opioid Sparing Outcomes, Non-Opioid Alternatives To Get Spotlight From US FDA Advisory Cmte.

The advisory committee will discuss a broad range of questions on a facet of FDA's opioid strategy that has received less attention than the others.
Advisory Committees Neurology

Keeping Track: Yupelri Is Latest Novel Drug Approved, But Bad News For Biosimilars

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

Gottlieb Renews Call For New Opioid Review Paradigm As Democrats Prepare For House Control

US FDA's controversial approval of Dsuvia may prompt incoming House Democrats to pay special attention to commissioner's remarks on how agency reviews opioids. 
Neurology Elections

Democrat-Controlled House Will Turn Up The Volume On Drug Pricing

With US House of Representatives now controlled by Democrats, lower chamber of Congress will likely increase hearings and investigations into industry pricing practices, but any legislation will probably need to dovetail with President Trump’s agenda to advance.

Legislation Pricing Debate

Democrat-Controlled House Will Turn Up The Volume On Drug Pricing

With US House of Representatives now controlled by Democrats, lower chamber of Congress will likely increase hearings and investigations into industry pricing practices, but any legislation will likely need to dovetail with President Trump’s agenda to advance.
Legislation Pricing Debate
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