Warning Letter Close-Outs – October 2022
Executive Summary
The US FDA released one close-out letter in October, resolving a 2021 COVID-related warning letter.
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Risk/Benefit Of CAR-T For Autoimmune Diseases May Shift With FDA Investigation
CAR-T therapy-associated T-cell malignancies that the US FDA is investigating could make the treatments less attractive in autoimmune diseases than in oncology, but patients in both settings already accept some cancer risk with other available medicines.
Pragmatic Oncology Trials: Survival Is Only Viable Endpoint For Now; FDA Emphasizes Streamlining
Overall survival is the only viable endpoint for pragmatic trials in oncology, the US FDA and a panel of stakeholders agree, although other novel endpoints could be validated over time. In the meantime, FDA says, sponsors should focus on other aspects of trials that can be streamlined.