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Monkeypox: US Gov’t Leaders Say Tpoxx Needs Randomized Control Trial Before Treatment For All

 
• By Sarah Karlin-Smith

Media reports have emphasized the public’s frustration with gaining access to Tpoxx, an antiviral that may help treat monkeypox. But top officials at FDA, CDC and NIH defend the need to study the drug more first, even as they note they are making expanded access easier.

hand pulling paper out of jar
Federal officials say randomized research, not just expanded access, needed for potential monkeypox treatment • Source: shutter stock

Federal officials make the case for studying Tpoxx (tecovirimant) for monkeypox in randomized controlled trials in an opinion piece in the New England Journal of Medicine on 3 August, amidst clamor for the drug under expanded access and criticism of the hoops required to get the drug through that compassionate use process.

Authors of the NEJM piece, led by US Food and Drug Administration Office of Infectious Diseases Deputy Director Adam Sherwat,...

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More from United States

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

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• By Cathy Kelly

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• By Derrick Gingery

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Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

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More from North America

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.