Fierce Biotech

FDA steers cancer CAR-T developers toward randomized superiority trials in policy shift

The FDA is raising the bar for approval of CAR T-cell therapies in oncology. | The FDA is raising the bar for approval of CAR T-cell therapies in oncology. Under plans outlined by the FDA’s biologics chief Vinay Prasad,
Fierce Pharma

A dozen former FDA commissioners blast Prasad's proposed vaccine policy changes

Drastic overhauls of U.S. vaccine regulations proposed by top FDA official Vinay Prasad, M.D., have drawn harsh pushback from 12 former commissioners of the agency. | Drastic overhauls of U.S. vaccine regulations proposed by top FDA official Vinay Prasad,
Becker's Hospital Review

The FDA’s new vaccine approval roadmap, explained

The FDA vaccine approval road map proposes longer trials and stricter evidence to improve vaccine safety and effectiveness oversight.
STAT

Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks

In a closed meeting, Vinay Prasad pushes back on criticism of his vaccine policy changes, morale issues at the FDA, and his role in recent drug-approval turbulence.
Fierce Pharma

FDA's Prasad tells staffers agency plans to get tougher on vaccine regulation, blames child deaths on COVID shots

In the wake of the memo, several vaccine experts responded that the CBER director's claim about the deaths requires more scrutiny. In a disclaimer on the Vaccine Adverse Event Reporting System (VAERS) website, the HHS notes that the data alone "cannot be used to determine if a vaccine caused or contributed to an adverse event or illness."
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