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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

Drug/Software Combos Likely Won't Require Pre-Market Review By US FDA

The agency explains that most drug-use-related apps will be considered promotional labeling, but sponsors should sometimes seek advisory comment. US FDA is seeking feedback from a variety of stakeholders on its discussion proposal for regulating prescription-drug-focused software.

Digital Health Advertising, Marketing & Sales

Pain Therapeutics Appeals Remoxy CRL In Likely Last Ditch Effort To Save Abuse-Deterrent Opioid

Meeting with US FDA in January will aim to reverse fourth rejection in 10 years; firm still criticizing agency even as it works to reconcile their positions.
Complete Response Letters Neurology

Drug/Software Combos Likely Won't Require Pre-Market Review By US FDA

But sponsors should sometimes seek advisory comment. Agency explains that most drug-use-related apps will be considered promotional labeling. FDA seeking feedback from a variety of stakeholders on its discussion proposal for regulating prescription-focused software.

Digital Health Advertising, Marketing & Sales

Keeping Track Of Approvals: Cancer, Cancer, And A Two-Week Cancer Review

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

Keeping Track Of Breakthrough Therapy Designations: Depression, Headaches, Hepatitis

The latest developments in one of the US FDA's favorite pathways.

US FDA Performance Tracker Review Pathway

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
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