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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

Could New Governments In Brazil, Mexico Derail International Regulatory Convergence?

Bayer's Patrick Brady says nationalist sentiments raise concerns, but he remains hopeful that technology and progress will continue to drive globalization.
Regulation Policy

Keeping Track: Rebuff Of Iclaprim Creates Early Pileup Of CRLs For Novel Drugs

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

Ways And Means Drug Pricing Hearing Emphasizes Repetitive, Years-Old Questions

There was little on specific legislative proposals and a lot of time discussing broad questions that Congress has been asking for years about drug pricing.

Pricing Debate Legislation

REMS Abuse Website: Has It Changed The Behavior Of Innovators?

Updated numbers from the US FDA's REMS abuse website show that Celgene has received two additional safety determination letters, raising question's about whether the public list has changed the practices of brand companies hindering generic company access to samples.
Generic Drugs Risk Management

Keeping Track: CDER Approves Its First Two Novel Agents Of 2019

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

US FDA Wants Opioid Prescribing Guidelines To Be Highly Specific, But It May Have To Compromise

National Academies of Sciences, Engineering, and Medicine committee meeting suggest it is difficult to write condition-specific guidelines for opioid prescribing in the primary care setting.
Drug Safety Regulation
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