Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

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.
Advertisement
Set Alert for Articles By Michael Cipriano

Latest From Michael Cipriano

FDA Safety Meetings: Outpatient Drugs, Hypoglycemia Getting Limelight

US agency's events could address a touchy subject: how much responsibility does FDA have for preventing adverse events, and how much falls to physicians?

Drug Safety Risk Management

Brazil Patent Agreement Hopes To Increase Flow Of Generics To Market

Joint ordinance signed by Anvisa and INPI hopes to resolve a 16-year impasse between the two agencies and bring predictability to patent application process; Anvisa will be relegated to analyzing public health matters, while INPI will make final patentability determinations.

Intellectual Property Regulation

Flexible 'Menu' Of Antibacterial Development Options Suggested By US FDA Panel

FDA should consider allowing sponsors in challenging area of single species antibacterials more flexibility in study designs, advisory committee suggests, despite disagreement over approaches such as animal models and non-inferiority trials.

Infectious Diseases Advisory Committees

Abuse-Deterrent Opioids: Postmarketing Data Eyed As Development ‘Anchor’

Panelists at US FDA advisory committee on Inspirion's RoxyBond note reservations about abuse-deterrent claims absent more real-world data on how they work; FDA's Staffa suggests agency is eager to see how well premarket work predicts postmarket experience – though the data are far from being available.

Advisory Committees Post Market Regulation & Studies

Antibacterial Drugs: FDA Panel To Explore Approval Path For Single-Species Agents

US agency’s advisory committee will weigh the pros and cons of five possible development and regulatory pathways, with a specific focus on animal models.

Research & Development Regulation

RoxyBond Gets US Advisory Panel OK For Abuse-Deterrent Claim Despite Excipient Concerns

Members unanimously endorse product and mostly supported abuse-deterrent language; several panelists suggest warning about possible harmful effects of excipients by abusing product intravenously.

Advisory Committees Drug Review
See All
Advertisement
UsernamePublicRestriction

Register