Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.
Set Alert for Articles By Michael Cipriano

Latest From Michael Cipriano

US FDA Drug Risk Management Board To Be Lead By CDER Deputy Cavazzoni

CDER Director Woodcock announced that the drug center will soon launch the Drug Risk Management Board, which will coordinate product safety activities among the different offices; Patrizia Cavazzoni, who serves as CDER's deputy director of operations, will chair the board.

Drug Safety FDA

Keeping Track: Nektar Withdraws Oxycodegol NDA As Novel Submission Pileup Continues

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

US FDA Performance Tracker Drug Review

Nektar's Novel Opioid Unanimously Rejected by US FDA Advisory Cmte.

But more data on abuse potential and efficacy could offer path for forward for oxycodegol even after the FDA product-specific advisory committee meeting for an opioid analgesic in more than a year goes very badly for the sponsor.

Advisory Committees Neurology

Nektar's Novel Opioid For Lower Back Pain Heads To US FDA Panel For Wide-Ranging Discussion

Nektar's novel opioid oxycodegol will be the first opioid analgesic taken up by an advisory committee in more than a year after the agency spent 2019 reevaluating its regulatory paradigm.

Advisory Committees Neurology

Keeping Track: Ayvakit Approval, Keytruda Supplement, NME Submissions

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

US FDA Performance Tracker Approvals

Pink Sheet Podcast: The Most Impactful Stories Of 2019

Pink Sheet reporters review the major issues that emerged during the past year and how they will impact 2020.
FDA Leadership
See All
UsernamePublicRestriction

Register