This article was originally published in SRA
Extension to types of medicinal products sold outside pharmacies
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Two top officials in the US FDA’s device center are warning of delays in the agency’s review of submissions for new products that aren’t directly tied to the coronavirus pandemic.
With 12 new BTDs announced so far this year, 2021 is on pace to match the COVID-19-depressed total number of designations in 2020. Here’s a breakdown of the candidates that have received the designation.
Popular expedited review program results in a higher approval rate than the related fast track designation, but the COVID-19 era is seeing a drop in designations and a rise in complete response letters for BTD programs.