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  1. Advancing Regulatory Science

Priority Area 3: Support New Approaches to Improve Product Manufacturing and Quality

Inspectors testing new manufacturing technologies and manufacture of biological products


Application of new science and technologies is leading both to innovation in manufacturing and to innovative products that are often complex. To foster these innovations, FDA is conducting research – collaborating with industry and academia – to assess how these new technologies affect product safety, efficacy, and quality, and using the information to inform development of regulatory policy relevant to these innovations.

The BAA-funded research projects below aim to enable the development and evaluation of new and improved manufacturing methods; develop new analytical methods; and reduce the risk of microbial contamination of products.

Extramural Research Funded through the BAA

  1. Continuous Manufacturing of Liposomal Drug Formulations
  2. Subvisible Protein Aggregates in Biologics - Analytical Methods and Monocyte Response
  3. Development of an Evaluation Framework for Measuring the Health and Efficacy of Intramural Research Programs in FDA's Medical Device Center
  4. Advancing Continuous Flow Reactor Technology Through Real-Time Control and Product Isolation for Improved Quality Assurance and Consumer Safety
  5. Computational drug delivery: leveraging predictive models to develop bioequivalent generic long-acting injections
  6. Genome Sequencing of Diverse Pathogens in Support of FDA-ARGOS
  7. Comparative Surveillance of Generic Drugs by Machine Learning
  8. Glycoproteomics Characterization Workflow and Data-Analysis Pipeline for Vaccines and Biosimilars
  9. Computational Model and Wireless Pharmaceutical Analysis Device to Measure in Vivo Drug Dissolution in GI Tract and To Distinguish Meaningful Product Quality Differences and Ensure Bioequivalence (BE) in Patients
  10. Innovations in Regulatory Science: In Vivo Predictive Dissolution (IPD) to Advance Oral Product Bioequivalence (BE) Regulation
  11. Influence of raw materials, manufacturing variables, and storage conditions on release performance of long-acting release microsphere products
  12. Advanced Analytical Techniques for Mixed Polymer Drug-Delivery Systems
  13. Assessment of the In Vitro Percutaneous Absorption, In Vitro Rate of Release, and Physicochemical Properties of Selected Commercially Available AT Rated Ointment Formulations
  14. Critical Process Parameters for the Preparation of Amphotericin B Liposomes
  15. Evaluation of Model-Based BioEquivalence (MBBE) statistical approaches for sparse designs
  16. Mass Spectrometry Profiling of Pentosan Polysulfate in Urine
  17. Pharmacokinetic Comparison of Locally Acting Orally Inhaled Drug Products