2021: Focus Areas of Regulatory Science (FARS)

Four focus areas for regulatory science research for innovative products, to inform regulatory decision-making and improve sponsor guidance to sponsors

  • Public Health Preparedness and Response: Medical countermeasures and preparedness, Reduce pathogen contamination, Substance Use disorders, Antimicrobial resistance, Food safety, Compounded drugs
  • Increasing Choice and Competition through Innovation: Individualized therapeutics and Precision Medicine, Complex innovative trial design, Microbiome research, Novel foods and food ingredients, Regenerative medicine, Advanced manufacturing, Generic alternatives for complex drugs, Product Development Tools
  • Unleashing the Power of Data: Product safety surveillance, Diverse data and technologies (AI, digital health, real-world evidence
  • Empowering Patients and Consumers: Preferences and perspectives, PROS and COAs, make better-informed decisions


Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan

Total product lifecycle-based regulatory oversight to deliver safe and effective software functionality for AI/ML-based SaMD

  • Update proposed framework for AI/ML-based SaMD, including through issuance of draft guidance on the Predetermined Change Control Plan
  • Encourage harmonization of Good Machine Learning Practice (GMLP) development
  • Hold public workshop on device labeling to support transparency to users and enhances trust in AI/ML-based devices
  • Develop methodology for evaluation and improvement of ML algorithms, including identification and elimination of bias, evaluation and promotion of algorithm robustness
  • Piloting Real-World Performance (RWP) process for AI/ML-based SaMD


Advanced Manufacturing Technologies

Importance of regulatory programs for advancing manufacturing, computational modeling, and other emerging technologies

  •  New collaboration with the National Institute of Standards and Technology (NIST)  to increase U.S. medical supply chain resilience and manufacturing of drugs, biological products, medical devices through adoption of 21st century manufacturing technologies
  •  New initiatives for advanced manufacturing : CDER Emerging Technology Program, CDRH Case for Quality, CBER Advanced Technologies Program


Learnings from 2020 New Drug Therapy Approvals

Meeting challenges to respond to the COVID-19 pandemic while bringing safe and effective new drug therapies for a range of other diseases and conditions

  • Innovation across different medical conditions:  Infectious diseases, Neurological advances, Heart, blood, kidney, and endocrine disease advances, Autoimmune conditions, wide array of cancers
  • New therapies for rare diseases: Including ebola and rare cancers
  • Review efficiencies: Meeting PDUFA goals, first cycle approvals, expedited programs


Medical Device Regulatory Flexibility

Medical device enforcement policies responsive to public health emergency (PHE)

  • Review of products relevant to PHE
  • Review of MAUDE database for adverse events reports related to use during pandemic
  • Based on de minimis number of adverse events, immediately exempting 7 devices from the premarket notification requirement, and proposal to exempt an additional 84 devices after public comment is closed


Image credit: FDA