FDA Commissioner Makary sits down for a conversation with the newly appointed director of the Center for Biologics Evaluation and Research (CBER) Dr. Vinayak “Vinay” Kashyap Prasad and Sanjula Jain-Nagpal, Associate Director of Policy & Research Strategy, Office of the Commissioner (OC). The trio talks about the current and... future happenings at the FDA.show more

“We aren’t sure about kids” or “healthcare workers who’ve just had Covid if they need a booster”. @VPrasadMDMPH actually said that out loud, in 2025, as if the evidence isn’t crystal clear by now of how Covid affects children or healthcare workers. He should read some studies.

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Good to hear Vinay state publicly RCTs may not be appropriate pre-approval for rare diseases. RCTs are similarly challenging in precision oncology (the future of oncology). Real-world control arms are useful. @Dr_R_Kurzrock @VivekSubbiah @VPrasadMDMPH

Love to see this administration opening it's opinions up to the public. Glass box >>> black box!

This is a useful early look towards agency thinking,allowing narrative control on priorities/view points. The comments on FDA transparency, American public focus, innovation and solidified philosophical goal posts should resonate with individuals, industry + investors alike.Tx

Do regular chats so people know what's happening. Why not?

Fantastic conversation. Been following Marty & Vinay’s work for years now. In regards to the topic of inviting “stakeholders” to the campus and opening up the conversation, please include discussions of psychedelics and how the FDA can evaluate the strong evidence & move forward

@MartyMakary the guy who says regulatory flexibility and accelerating timelines for approval appoints a guy who doesn’t believe in surrogate endpoints in lieu of maturing OS data. We can’t trust anything you say anymore

Two great physicians who have brought a common sense, balanced and scientifically nuanced approach to the FDA.

from blackbox to glassbox, FDA is going to win public support and trust, and serve American citizens better. One suggestion: please publish CRL letters to tell every one why a drug is not approved.