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

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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

Boehringer Avoids Further Efficacy Study Of Ofev In SSc-ILD With Full Approval, No Post-Marketing Commitments

Despite concerns from members of US FDA's Arthritis Advisory Committee that the efficacy profile of Boehringer Ingelheim's Ofev needs more study in the SSc-ILD indication, the company does not have any such postmarketing requirements or commitments.

Approvals Immune Disorders

Keeping Track: Ofev Snags SSc-ILD Indication, Accelerated Approval Reviews For Veverimer And Voxelotor, J&J Gets Its First Vaccine BTD

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

US FDA Performance Tracker Approvals

Pink Sheet Podcast: Sharpless' Future, Sharpless On Data Manipulation, and Mylan's Insulin Complete Response Letter

Pink Sheet reporters discuss the questions about Acting Commissioner Norman Sharpless' future at the US FDA, his comments about the data manipulation scandal, and the complete response letter that is delaying Mylan's follow-on insulin product.

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