💊FDA Workshop on Patient Experience Data and Drug Development
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Patient-Focused Drug Development: Workshop #2 to Discuss Methodologic and Other Challenges Related to Patient Experience Data." The purpose of the public workshop is to discuss methodological challenges related to patient experience data, and other areas of greatest interest or concern to public stakeholders.
Learn More💊FDA Workshop on CMC Development
The Food and Drug Administration (FDA, the Agency, or we) is announcing a virtual-only public workshop entitled "Lessons Learned From the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program." This workshop fulfills a commitment in the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII) to hold a public meeting to discuss best practices and lessons learned from this pilot program. Convened by the Duke-Robert J. Margolis, MD Center for Health Policy (Duke-Margolis) and supported by a cooperative agreement between FDA and Duke-Margolis, the workshop will feature sponsors and FDA experience under this pilot program and will solicit input on future directions for FDA policy and programs to facilitate expedited CMC development of products under an investigational new drug application (IND), where indicated based upon the anticipated clinical benefits.
Learn More💊FDA Workshop on Advancing Development of Interchangeable Products
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Advancing the Development of Interchangeable Products: Identifying Future Needs." The purpose of the public workshop is to address a commitment FDA made in the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years (FYs) 2023 through 2027 (BsUFA III) to hold a scientific workshop to discuss and identify future needs (e.g., guidance, research) that, when addressed, may help further advance the development of interchangeable biosimilar products.
Learn More🏥FDA Workshop on Optimizing Pregnancy Registries
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Optimizing Pregnancy Registries." The purpose of the public workshop is to discuss challenges in designing and implementing pregnancy registries and to consider innovative approaches to improve the design and conduct of pregnancy registries to inform the safety of drug and biological products during pregnancy. This public workshop is being held in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation program.
Learn More🧬FDA Workshop on Cell Therapies
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public workshop entitled "Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development." The purpose of this workshop is to discuss the current state of the science for development and testing of certain cellular therapies and tissue-based products. In particular, FDA is convening this public workshop with relevant stakeholders to discuss best practices on generating scientific data necessary to further facilitate the development of cellular therapies, including stem cell products.
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