Opportunity Information: Apply for RFA FD 21 017
Apply for RFA FD 21 017
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, science and technology and other research and development sector is offering a public funding opportunity titled "Renewal : UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (U01) Clinical Trials Optional" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Feb 18, 2021.
- Applicants must submit their applications by May 25, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2024.)
- Each selected applicant is eligible to receive up to $16,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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Apply for RFA FD 21 017
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Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks and Pediatric Anesthesia Safety Initiative (ACTTION/PASI) (U01) Clinical Trial Not Allowed) Apply for RFA FD 22 023 Funding Number: RFA FD 22 023 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $3,000,000 |
Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional Apply for RFA FD 22 026 Funding Number: RFA FD 22 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required Apply for FOR FD 23 007 Funding Number: FOR FD 23 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $650,000 |
Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models Apply for RFA FD 23 016 Funding Number: RFA FD 23 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $500,000 |
Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed Apply for RFA FD 23 012 Funding Number: RFA FD 23 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $1,200,000 |
Evaluation of oral modified release drug tablet to support the approval of additional strengths Apply for RFA FD 23 013 Funding Number: RFA FD 23 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $450,000 |
Novel approaches to support therapeutic development in ultra-rare cancers Apply for RFA FD 23 008 Funding Number: RFA FD 23 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,500,000 |
In Vitro Based Approaches to Evaluate the Bioequivalence of Prospective Generic Rectal and Vaginal Products (U01) Clinical Trial Not Allowed Apply for RFA FD 23 014 Funding Number: RFA FD 23 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
Applied Regulatory Science Research to Understand Factors that Affect the Safety and Efficacy of Underrepresented Populations in Oncology Therapeutic Development (U01) Clinical Trial Optional Apply for RFA FD 23 006 Funding Number: RFA FD 23 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,500,000 |
Site Selection in Oncology Clinical Trials: Considerations for Selecting Sites in Limited Geographic Regions or Areas of Political Unrest, Limiting Inspection Capabilities (U13) Clinical Trial not allowed. Apply for RFA FD 23 007 Funding Number: RFA FD 23 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $300,000 |
Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional Apply for RFA FD 23 015 Funding Number: RFA FD 23 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $750,000 |
Pediatric Device Consortia Grants Program (P50) Clinical Trials Optional Apply for RFA FD 23 024 Funding Number: RFA FD 23 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $5,000,000 |
Natural History and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional Apply for RFA FD 23 028 Funding Number: RFA FD 23 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed Apply for RFA FD 23 029 Funding Number: RFA FD 23 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $5,500,000 |
Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required Apply for RFA FD 23 001 Funding Number: RFA FD 23 001 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $650,000 |
Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed Apply for RFA FD 23 017 Funding Number: RFA FD 23 017 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $500,000 |
Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional Apply for RFA FD 23 026 Funding Number: RFA FD 23 026 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
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