Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies (U01)

The goal of this program is to support the advancement of regulatory science that can facilitate the implementation and the assessment of emerging manufacturing technology in the pharmaceutical sector. Emerging manufacturing technology can be viewed as a technology that has the potential to modernize the pharmaceutical manufacturing body of knowledge to support more robust, predictable, and/or cost-effective processes and with which the FDA has limited review or inspection experiences, due to its relative novelty. Examples of such elements include an innovative or novel: (1) product manufacturing technology, such as the dosage form; (2) manufacturing process (e.g., design, scale-up, and/or commercial scale); and/or (3) testing technology.