Understanding preservative effects on bioequivalence of topical ocular product
Active Definitive Contract Awarded Last action
- Contract number
- 75F40123C00205
- Awardee
-
Ita-Suomen Yliopisto UEI D7PPMMNACBA1
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $1,000,995
Award facts
- Opportunity
-
- FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Solicitation · FDABAA2300123 · Posted Nov 14, 2022
- Contract value 100% obligated
- $1,000,995.00 Current and potential, with all options
- Completion date 97% complete
- Current and potential, with all options
- Contracting staff
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- PSC
- R499 Support- Professional: Other
- Set-aside
- No set-aside
- Competition
- Full and Open Competition · 1 offer Two Step
- Pricing
- Firm Fixed Price
- Place of performance
- Finland
Award details come from SAM.gov/FPDS.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Exercise an Option | $226,800 | |
| Other Administrative Action | $0 | |
| Exercise an Option | $358,495 | |
| Original award | $415,700 |
About this award
The Food and Drug Administration awarded a $1.0M firm fixed-price contract to Ita-Suomen Yliopisto (University of Eastern Finland) on September 29, 2023, to conduct research on understanding preservative effects on bioequivalence of topical ocular products. The contract, which extends through November 30, 2026, was awarded under the FDA's Broad Agency Announcement for Advanced Research and Development of Regulatory Science. This research effort supports the FDA's mission to modernize product development and evaluation methodologies, specifically addressing how preservatives impact the bioequivalence of ophthalmic formulations—a critical consideration for generic drug approvals and product labeling. No set-aside designation was applied to this award. The research will be performed in Finland and represents the FDA's investment in international academic collaboration to advance regulatory science capabilities.
The contract aligns with the FDA's three-pronged research strategy outlined in the BAA: modernizing product development and evaluation, strengthening post-market surveillance and labeling, and invigorating public health preparedness. Ita-Suomen Yliopisto, a multidisciplinary research institution, brings relevant expertise from prior collaborations on pharmaceutical and medicinal chemistry research. The University of Eastern Finland is well-positioned to contribute to FDA's regulatory science objectives through systematic investigation of preservative formulations in topical ocular products, which will inform future regulatory guidance and approval pathways for similar therapeutic products.
Quick answers
Who was awarded contract 75F40123C00205?
75F40123C00205 was awarded to Ita-Suomen Yliopisto by Food and Drug Administration (Department of Health and Human Services) on September 29, 2023.
How much is contract 75F40123C00205 worth?
The government has obligated $1,000,995 on 75F40123C00205.
Was contract 75F40123C00205 competed?
The extent of competition for 75F40123C00205 was full and open competition. The government received 1 offer.
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