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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

Woodcock: Concerns About US FDA's Biosimilars Suffix Policy Detached From Reality

In an exclusive interview, Center for Drug Evaluation and Research Director Janet Woodcock contends that industry concerns about FDA's new suffix policy aren't reflective of real-world problems.
Biologics Biosimilars

Gottlieb Touts US FDA's Organizational Structure For Advancing Policies During His Tenure

Outgoing FDA commissioner said his direct contact with center directors helped agency advance policies and helped centers solve their problems.

Leadership FDA

Latin America Notebook: Advancing Adaptive Trial Designs, Translating ICH Guidelines, Sharing Confidential Information

Brazil's drug regulator ANVISA will require more experience in dealing with adaptive trial designs before issuing guidance; translating older ICH guidelines remains a barrier to their implementation; and industry is asked to be more transparent in sharing their confidential information among drug regulators to facilitate convergence.

South America Clinical Trials

Keeping Track: Two Goal Date Extensions, Another Herceptin Biosimilar Approval, And A BLA Withdrawal

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

Trump FY 2020 Budget Renews Push To Reform 180-Day Exclusivity

US FDA would get an overall increase in funding under the president's fiscal year 2020 budget proposal, although the generic drug industry opposes reforms targeting the 180-day exclusivity clock for first filers.
Generic Drugs Legislation

Keeping Track: Accelerated Approval For Tecentriq And A Burst Of Filings And Submissions

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