Definitive Contract 75F40126C00025
- Not listed
- The Food and Drug Administration awarded a $248,553.46 definitive contract to Institute For Clinical Pharmacodynamics, Inc. for development of modernized susceptibility guidance for nitrofurantoin dosing using dynamic urinary tract in vitro infection modeling and pharmacometric approaches on August 19, 2024. The award stems from an FDA Broad Agency Announcement soliciting advanced research and development proposals to support regulatory science, with a two-stage review process (concept paper due...
- This $291,618 definitive contract was awarded by the Food and Drug Administration (FDA) to the Institute For Clinical Pharmacodynamics, Inc. (ICPI), a for-profit, minority-owned organization. The contract is in support of the FDA's Combatting Antibiotic Resistant Bacteria (CARB) program and will have a period of performance through September 29, 2023. Under this contract, ICPI will provide pharmacometric analysis and modeling services to the FDA to support updating clinical breakpoints for the...
- The Food and Drug Administration awarded an $811,126 definitive contract to Digital Medicine Society Inc. on September 13, 2024, for development of a guide for technology developers and the life sciences, with ultimate completion by December 31, 2025. The contract derives from BAA FY24C1DP11, an FDA Broad Agency Announcement soliciting research and development proposals to support regulatory science across modernizing product development and evaluation, strengthening post-market surveillance and...
- This is a $1,904,355.00 definitive cost-no-fee contract awarded by the Food and Drug Administration (FDA), a civilian government agency, to the Institute Of Quantitative Systems Pharmacology, a non-profit organization. The contract is for basic and applied research with two key objectives: (1) to test the hypothesis that variabilities in nanoparticle (NP) properties and tumor targets cause uncertainties in "FORMULA", and (2) to develop computational models to predict the...
- The U.S. Food and Drug Administration (FDA) awarded a $1,155,442.55 Cost Plus Fixed Fee contract to Cubrc, Inc. to conduct research and development on the "Immunogenicity Risk of Peptide Drug Generics and Their Impurities: In Silico and In Vitro Assessment and Validation Methods." The contract, which has a period of performance ending September 27, 2022, was issued under the FDA's Broad Agency Announcement (BAA) solicitation for advanced research and development to support regulatory...
- The Food and Drug Administration (FDA) awarded a $3 million cost-plus-no-fee definitive contract to the National Institute for Pharmaceutical Technology & Education Inc. (NIPTE) to conduct research and development on continuous drug substance manufacturing from biomass-derived building blocks. The award, made on September 22, 2022, through the FDA's Broad Agency Announcement mechanism, supports the agency's broader regulatory science initiative to develop new tools, standards, and approaches...
- The Food and Drug Administration awarded a $307,205 cost-no-fee contract to The Johns Hopkins University under Broad Agency Announcement PMWP#173 to evaluate the impact of extended-infusion beta-lactam administration strategies on improving clinical outcomes and reducing the subsequent emergence of antimicrobial resistance. The contract was awarded through the Department of Health and Human Services' Fiscal Year 2021 FDA Broad Agency Announcement for Advanced Research and Development of...
- The National Institute of Allergy and Infectious Diseases awarded a cost-plus-no-fee definitive contract to The Research Foundation For The State University Of New York for comprehensive quality assessment programs supporting clinical pharmacology laboratories that test samples from NIAID-supported clinical studies on May 30, 2022. The contract ceiling is $17.572 million with an ultimate completion date of May 29, 2029. The originating pre-solicitation, posted in December 2020, describes a...
- Landrau Scientific Innovations LLC was awarded a $567,980 firm fixed price definitive contract by the Department of Health and Human Services Food and Drug Administration to support the agency's Broad Agency Announcement PMQWP#237. This BAA seeks advanced research and development proposals to evaluate critical process parameters for the preparation of amphotericin B that influence toxicity, advancing the FDA's regulatory science and innovation goals. The prime contractor will conduct work at its...
- The Food and Drug Administration awarded a purchase order to Chapter Diagnostics Inc. for $130,000 on July 11, 2023, to design and develop next-generation targeted sequencing reagents, baits, and software for the detection and typing of Campylobacter spp. from food and environmental matrices. The order is set-aside for total small business. Work is performed in Menlo Park, California. The procurement originated from a special notice posted June 8, 2023, with a June 23 response deadline. Ultimate...
The Food and Drug Administration awarded a $325,000 definitive contract to Institute For Clinical Pharmacodynamics, Inc. on August 1, 2026, for development of susceptibility guidance for daptomycin and enterococcus species using pharmacometric approaches under the FY26 FDA Broad Agency Announcement for Advanced Research and Development of Regulatory Science. Place of performance is Schenectady, NY. The contract runs through July 31, 2027, under firm fixed price terms with no set-aside. The originating BAA solicitation, posted November 21, 2025, seeks basic and applied research and development to support regulatory science and innovation across FDA-regulated domains, with three key charge areas: modernizing development and evaluation of FDA-regulated products, strengthening post-market surveillance and labeling, and invigorating public health preparedness and response. The BAA encompasses research priority areas including new approach methodologies, analytical and computational methods, biomarkers, and clinical outcome assessments. The solicitation is classified under NAICS 541714 (Research and Development in Biotechnology) and PSC code AJ11 (General Science and Technology R&D Services). Multiple awards are anticipated under the BAA, which operated under FAR 6.102(d)(2) and 35.016, with a two-stage submission process and Stage One packages due February 24, 2026.
Name | Description | Solicitation Number | FederalAgency | Type | PostedDate |
|---|---|---|---|---|---|
FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science | FDABAA-26-00123 | Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services | Special Notice 1/1 | 11/21/25, 8:57 AM |
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | Not listed | $325.0k | 6/29/26 |