The FDA has issued a warning letter to Ocular Therapeutix regarding the company’s compliance with data collection and information reporting obligations related to the premarket approval application for ReSure Sealant, according to a company press release.
Ocular Therapeutix is required to provide periodic reports on the progress of a post-approval Device Exposure Registry study as a condition for approval.
The company is “committed to working with the FDA to address and resolve the concerns cited in the warning letter” and intends to respond within the required 15 days, the
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