Definitive Contract 75F40123C00205

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.