FDA issues guidance on implementing decentralized elements in clinical trials

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.

May 09, 2025

Vol.51 No.18

By Claire Marie Porter

Cancer Policy

Scott Gottlieb, Mark McClellan warn of the major challenges created by planned reorganization of FDA

Scott GottliebMark B. McClellanTwo former FDA commissioners—Scott Gottlieb and , Mark B. McClellan—

First ODAC meeting since Trump’s inauguration scheduled for May 20-21

FDA announced a meeting of the Oncologic Drugs Advisory Committee May 20 and 21. It will be the first ODAC meeting since President Trump was inaugurated.

FDA grants accelerated approval to avutometinib + defactinib for KRAS-mutated recurrent LGSOC

FDA granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy.

May 09, 2025

Vol.51 No.18

Clinical Roundup

Sotorasib + panitumumab offers better outcomes in colorectal cancer that no longer responds to treatment

A novel combination therapy offers better outcomes for patients with KRAS G12C metastatic colorectal cancer that have stopped responding to chemotherapy, according to a phase III clinical trial by researchers at City of Hope.

May 02, 2025

Vol.51 No.17

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.

April 25, 2025

Vol.51 No.16

By Claire Marie Porter

FDA issues guidance on implementing decentralized elements in clinical trials

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

Scott Gottlieb, Mark McClellan warn of the major challenges created by planned reorganization of FDA

First ODAC meeting since Trump’s inauguration scheduled for May 20-21

FDA grants accelerated approval to avutometinib + defactinib for KRAS-mutated recurrent LGSOC

Sotorasib + panitumumab offers better outcomes in colorectal cancer that no longer responds to treatment

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

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FDA issues guidance on implementing decentralized elements in clinical trials

YOU MAY BE INTERESTED IN

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

Scott Gottlieb, Mark McClellan warn of the major challenges created by planned reorganization of FDA

First ODAC meeting since Trump’s inauguration scheduled for May 20-21

FDA grants accelerated approval to avutometinib + defactinib for KRAS-mutated recurrent LGSOC

Sotorasib + panitumumab offers better outcomes in colorectal cancer that no longer responds to treatment

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

Never miss an issue!

Login

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

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