FDA hands a CRL to drugmaker Eton after a delayed inspection — but are Covid-19 travel restrictions really the issue?
For the second time in three years, Eton Pharmaceuticals has received a complete response letter from the FDA, this time for its dehydrated alcohol injection to treat methanol poisoning. The company blamed the delay on a missing inspection but also pointed to “other questions” from the agency.
On Friday, Eton disclosed it had received a letter from the agency, tying it to a pending pre-approval inspection of its European manufacturer due to Covid-related travel restrictions. But it’s worth noting that the FDA doesn’t issue CRLs based solely on inspection delays, an agency spokesman previously told Endpoints News, indicating there may have been other issues with Eton’s application.
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