Accelerated Approval, But Not Other Expedited Programs, Associated With More Postmarket Safety Changes
Smaller pre-approval safety databases generally didn’t correlate with an increased likelihood of postmarket safety events.
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Back to The Past: The Case for Improving Upon, Not Throwing Out Traditional Cancer Phase I Study Designs
US FDA has pushed sponsors away from the traditional dose-finding designs for cancer drugs in recent years. But academics continue to make a case for keeping the 3+3 design with some improvements.
Pfizer Comes Close To Meeting FDA’s Guidance Standard For COVID Booster Dose, But It May Not Be Enough
Study data met two key endpoints laid out in agency guidance, but Pfizer may not have enough evidence of the booster’s impact on current circulating virus variants, particularly Delta. It is also unclear if Pfizer has made the case to FDA that a booster dose is needed at this time or that they provided enough safety data.