The Wait is Over: FDA Publishes Fiscal Year 2021 User Fees for the Over-the-Counter Monograph Drug User Fee Program | Arnall Golden Gregory LLP
To embed, copy and paste the code into your website or blog: With only a few days left in 2020, a year that has been mostly focused on the Food and Drug Administration’s (FDA) Coronavirus pandemic response, the agency has taken another step to further implement the provisions of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that modernized the Over-the-Counter (OTC) Drug Review. On December 29, 2020, the FDA published a long-awaited Federal Register notice announcing the fee rates under the OTC Monograph user fee program for fiscal year 2021. [1] As discussed in prev...