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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: Approvals, A Burst Of Submissions, And Some Priority Reviews

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

Performance Tracker Drug Review

Antimicrobial Sponsors Should Update Labels Within Year Of Breakpoint Webpage Launch, US FDA Says

FDA recommends sponsors take the breakpoint information out of the labels for their approved antimicrobial products, and instead include a link to agency's newly launched website with breakpoint data.

Ingredients Infectious Diseases

US FDA Readies For Assessment Of IND Communications With Sponsors

Third-party contractor will conduct evaluation of agency's communications with sponsors throughout IND process as part of PDUFA VI commitments.

Drug Review FDA

Gene Therapy Guidances Will Focus On Specific Diseases, Gottlieb Says

US FDA's first such guidance will focus on hemophilia, commissioner tells Congress.

FDA Research & Development

US FDA Monitoring Online Forums For Research Into Opioid Misuse And Abuse

The goal of monitoring Twitter and chat rooms is to proactively identify patterns of misuse and abuse before they fully manifest, Commissioner Gottlieb says.

Drug Safety FDA

Breakthrough, Fast-Track Pathways Match Their Hype Of Reduced Development Times - JAMA

Although study was meant to be critical of expedited pathways, it showed that drugs with at least one of the designations experience lower clinical development times.

Review Pathway Drug Approval Standards
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