FDA moves to speed trials by reviewing AstraZeneca and Amgen data in real time, seeks public input on pilot program
The U.S. Food and Drug Administration announced a new initiative aimed at making clinical trials faster and more efficient.
As a first step, the agency will begin reviewing trial data in real time from ongoing studies run by AstraZeneca and Amgen, allowing earlier assessment of safety and efficacy.
The regulator also opened a public comment period on a proposed pilot program that would partner with pharmaceutical companies to further streamline trial processes.
In related news, Pfizer resolved patent disputes with three generic manufacturers concerning its heart drug Vyndamax, though the terms of the settlement were not disclosed.
This writeup was produced by pharmadog from original reporting by STAT.
Original headline: “STAT+: Pharmalittle: We’re reading about the FDA speeding up trials, a Supreme Court hearing on ‘skinny labels,’ and more”
read at STAT ↗
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