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  1. Advancing Regulatory Science

FDA Center/Office Regulatory Science Research Priority Areas for CERSI Program

FDA has identified the following priority areas for Center of Excellence in Regulatory Science and Innovation (CERSI) research, based on the Agency’s current unmet regulatory science needs. This list will be updated periodically as FDA’s needs change.

  1. High-priority topics, with needs across product lifecycle and relevant demographic groups (including but not limited to sex, gender, age, race, ethnicity, geography and analysis of difference between groups, where applicable):
    1. Tobacco, including, but not limited to toxicity, addiction, health effects, behavior, and communications. See link on CTP research priorities for more information.
    2. Advance development of individualized therapies
    3. Reducing healthcare-associated infection:
      1. Developing better understanding of the effectiveness of sterilization and reprocessing of medical devices
      2. Further developing pathogen-reduction technologies for whole blood and blood components
      3. Promoting development of innovative antimicrobial approaches
    4. Issues related to opioid use, misuse, and dependence
    5. Oncology, addressing key scientific questions that arise during regulatory review. See link on OCE Scientific Collaborative for more information
    6. Facilitating development of medical products to address the COVID-19 pandemic (diagnostics, therapeutics, vaccines, and products subject to EUAs/EUA expansion for the treatment, prevention, or diagnosis of COVID-19)
    7. Evaluating digital health technologies such as consumer-grade wearables to better measure patient experience living with disease and with medical products and AI/ML algorithm data sets.
  2. Develop and evaluate methods to improve quality and safety of FDA-regulated products for use by patients and consumers, including methods to improve predictive value of nonclinical evaluation
    1. Methodologies for development, manufacturing/quality control of complex generic drugs, biosimilars, biological products, and medical devices
    2. Biocompatibility and biological risk evaluation of medical devices and their component materials
    3. Evaluation of innovative methods such as:
      1. Microphysiological systems (MPS) (organs on a chip)
      2. Computer modeling and simulation (e.g., in silico clinical trials and biocompatibility modeling)
      3. Discovery and validation of minimally invasive biomarkers, particularly for diseases and medical states, where few markers exist (such as traumatic brain injury), including predictive microbiome biomarkers and use of current methods such as EEG and bio-imaging.
  3. Develop methods and tools to improve and streamline clinical and postmarket evaluation of FDA-regulated products, including
    1. Scientifically valid approaches to incorporating patient input (e.g., patient preference, patient reported outcomes) into regulatory decision-making
    2. Complex, adaptive, Bayesian, and other novel clinical trial designs
    3. Approaches to leveraging large, complex data to inform regulatory decision-making, including use of “real world” data sources and mobile technologies
    4. Evaluation of product safety and efficacy in special populations, including but not limited to pregnant individuals, lactating individuals, perinatal, pediatric, racial and ethnic minorities and older adults
    5. Inclusive demographic evaluations including but not limited to, age, sex, gender, race and ethnicity, and geography including analysis of:
      1. Safety and efficacy (e.g., analysis of sex, racial and ethnic differences in product safety)
      2. Effective comprehension and usability of FDA communications
      3. Global and US based clinical trial participation
    6. Develop and evaluate shared decision-making tools to better enable patients to make fully informed decisions about their use of medical devices. These tools may be created for priority areas such as dermal fillers, breast implants, or opioid use disorder devices.

See links on Office of Women's Health (OWH) Research Roadmap and Office of Minority Health and Health Equity (OMHHE) Research and Collaboration Program for more information.



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