FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science   2

Background
The FY26 FDA Broad Agency Announcement (BAA) aims to support advanced research and development of regulatory science. The initiative is led by the FDA, which is responsible for ensuring the safety and efficacy of food and drug products. The goal of this contract is to modernize the development and evaluation processes for FDA-regulated products, enhancing public health preparedness and improving regulatory science tools.

Work Details
The contract encompasses a variety of tasks aimed at modernizing the development and evaluation of FDA-regulated products. Key areas include:
1. Machine Learning-Guided 3D Nanoprinting for retinal vascular phantoms.
2. Development of a digital twin platform for breast cancer imaging.
3. Automated insulin delivery interoperability frameworks.
4. Enhancing health outcomes for older Americans and rural populations through clinical investigator readiness.
5. Strengthening post-market surveillance through virtual subject matter expert agents for radiology report evaluation.
6. Developing susceptibility guidance for antibiotics using pharmacometric approaches.
7. Creating high-throughput physiology tools for NAMs-based safety studies.
8. Establishing multiscale digital twin frameworks for flexible biomanufacturing.
9. Advancing AI-assisted digital twin platforms for real-time lyophilization process development.
10. Investigating the impact of diastereomers on oligonucleotide immunogenicity.

Period of Performance
The period of performance spans multiple years, aligning with the fiscal year 2026, indicating ongoing projects that may extend beyond a single year.

Place of Performance
Various locations across the United States including Maryland, California, New York, North Carolina, Massachusetts, Florida, Texas, and others as specified in individual project details.

Bidder Requirements
Bidders must demonstrate relevant experience in regulatory science and advanced research methodologies applicable to FDA-regulated products. Specific requirements may include professional certifications in relevant fields, security clearances where necessary, and proven capabilities in developing innovative solutions that align with FDA objectives.