FDA Commissioner Robert Califf said he hopes to see several priorities unfold in the coming years, including reorganizing the Office of Regulatory Affairs (ORA), more effectively harnessing real-world evidence (RWE) and taking an active role in combating misinformation.
During a wide-ranging virtual chat with the Alliance for a Stronger FDA on 22 August, Califf touched on several topics that are important to him. He also discussed the agency’s plans for its proposed unified human foods program (HFP) ahead of its hiring of James Jones to lead the effort.
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Multistakeholder collaboration, led by Catalyst Healthcare Consulting, to Recommend Data-Informed Optimization of CAR T-Cell Therapy Long-Term Follow-Up (preprint).
Understanding the patient experience with CAR-T long-term follow-up (LTFU) is essential for building a sustainable model. Catalyst...
Catalyst CEO, Nancy Myers, had the opportunity to address CBER leadership during OTP’s September 18th public listening meeting titled “Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies.” Though a PDUFA VII commitment and a required action, meetings like this one provide a critical space for industry and the Agency to share ideas and deliver better outcomes for patients.
Multistakeholder collaboration, led by Catalyst Healthcare Consulting, to Recommend Data-Informed Optimization of CAR T-Cell Therapy Long-Term Follow-Up (preprint).