Regulatory News

In first NCAB meeting since Trump’s inauguration, Lowy reflects on funding choices in lean times
Regulatory News

In first NCAB meeting since Trump’s inauguration, Lowy reflects on funding choices in lean times
“In the NCI director’s office, we have a photograph of a stone bridge, and it asks the question, which stone holds up the bridge? And the answer is all of them.”

In the first meeting of the National Cancer Advisory Board since the inauguration of President Donald Trump, NCI Principal Deputy Director Douglas R. Lowy addressed many of the burning questions the oncology field has for the institute. On indirect costs: NCI will continue to use previously negotiated and approved indirect cost rates, with the exception... […]
Cyber-iconoclast Vinay Prasad named head of FDA’s CBER
Regulatory News

Cyber-iconoclast Vinay Prasad named head of FDA’s CBER
An oncologist, Prasad has criticized accelerated approval, next-gen sequencing, and targeted therapies

Vinay Prasad, a MAHA-aligned hematologist-oncologist with an avid cyber following, was named director of the FDA Center for Biologics Evaluation and Research, where he will be responsible for the agency’s regulation of vaccines and biologics, including cell and gene therapies.
Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industry
Regulatory News

Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industry
Commissioner promises to protect scientific integrity while bringing in “fresh” MAHA ideas

In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models.