Tighter Route: FDA Will Require Randomized Controlled Trials (RCTs) for CAR T-Cell Therapy Approval
Numerous US pharmaceutical industry groups are urging the Food and Drug Administration (FDA) to expand the scope of the recently launched PreCheck Program. Initially focused on accelerating the establishment of new domestic manufacturing facilities, the industry is now advocating for the inclusion of existing factories and the integration of PreCheck with current regulatory initiatives. The main goal is to maximize the program’s impact to rapidly strengthen supply chain resilience and support the generic drug sector.
Mexico’s COFEPRIS Enhances New Molecules Committee to Accelerate Pharmaceutical Innovation
Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) has strengthened the expertise of its New Molecules Committee, a key regulatory body responsible for evaluating novel pharmaceutical agents. This initiative aims to enhance evidence-based decision-making, expedite drug approval processes, and expand public access to cutting-edge treatments. By integrating specialized experts, COFEPRIS seeks to streamline regulatory reviews and reinforce Mexico’s role as a leading hub for pharmaceutical research and innovation.
“The inclusion of these specialists will significantly enhance evidence-based decision-making with the highest scientific rigor,” stated COFEPRIS Commissioner Armida Zúñiga Estrada in a 14 March announcement. Furthermore, their work will have a direct impact on the availability of innovative treatments.