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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

FDA Final Guidance On Drug/Device Classifications Misses The Mark, Attorneys Say

The final guidance adds some requested clarifications, but does not appear to address the US agency's tendency to designate products as drugs over devices, industry attorneys argue.

Regulation Combination Products

Combo Product Classification Guidance Doesn't Fix All Existing Problems, Experts Say

US FDA's tendency to designate products as drugs over devices may remain despite clarifications offered in final guidance.

Review Pathway FDA

Drug Pricing Legislation Appears Nowhere In Sight Following Senate Hearing

Senators and witnesses rehashed years-old arguments and found little common ground on which elements of drug pricing to address.

Pricing Debate Reimbursement

NIH/Industry Oncology Partnership Aims For Immunotherapy Biomarkers

The US National Institutes of Health will team up with 11 different drug-makers to explore new biomarkers with a vision of precision oncology medicine.

Research & Development Personalized Medicine

Keeping Track: FDA Hands Out Complete Responses, Expedited Pathway Designations

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

Performance Tracker Drug Review

NIH/Industry Oncology Partnership Aims For Immunotherapy Biomarkers

Part of the Cancer Moonshot program, the five-year, $215 million research collaboration will be mostly funded by NIH with money from the 21st Century Cures Act.

Research & Development Cancer
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