Pfizer is a Fan of FDA’s Real-Time Oncology Application Review Process

Pfizer has expressed positivity towards the US Food and Drug Administration’s (FDA’s) Real-Time Oncology Review (RTOR) program. The RTOR will allow data submissions earlier in the review process in order to accelerate future decision-making and market access. Although the Alliance for Regenerative medicine has expressed concerns about the program, Pfizer is in support.

According to Pfizer, the FDA, “is directing sponsors to discuss the potential for using RTOR for cell and gene therapies with the appropriate review division. Pfizer supports the use of RTOR on these new and promising areas of drug development where it has the potential to streamline future reviews for the benefits of patients..”

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(Source: Endpoints News, September 28^th, 2022)