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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

Keeping Track: A Duo Of RTOR Approvals, Thumbs Up For First Oral GLP-1 Treatment, And First Ebola Vaccine Nears US Market

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

US FDA Performance Tracker Approvals

Pink Sheet Podcast: US FDA Launches Project Orbis And The Rare Disease Cures Accelerator, Looks For Abuse-Deterrent CNS Drugs

Pink Sheet reporters discuss the US FDA's work with other countries to review and approval of cancer therapies at the same time, a new database for rare disease clinical trial and natural history data, and the agency's exploration of abuse-deterrent CNS stimulants.

Drug Review Rare Diseases

Pain/Addiction Products Need Regulatory Streamlining To Incentivize Development, Sponsors Say

Industry speakers offer series of suggestions for ways to incentivize development of pain and addiction products at US FDA public meeting on the opioid crisis.

Review Pathway Research & Development

Keeping Track: US FDA Approvals For Ibsrela, Gvoke And Nucala; A BTD For Tepotinib

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

Pink Sheet Podcast: Upcoming Opioids Policy Meeting, Improving US FDA's Rare Disease Legalese

Pink Sheet reporters discuss the proposed US opioid lawsuit settlement, Public Citizen's opioid citizen petition denial, and the upcoming US FDA public meeting on opioid standards, as well as a proposal to better outline agency flexibility with rare disease drugs.

Drug Approval Standards Neurology

Expanded Access Program Improving, But Sponsor Concerns Linger

Many stakeholders interviewed by the GAO find the US FDA's updated guidance on treatment of adverse event data gathered under expanded access to be helpful, but some continue to be concerned that the data will be used to negatively impact development programs.

Clinical Trials Drug Safety
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