JD Supra

OTC Monograph Reform – Takeaways from FDA’s Webinar on Expedited Administrative Orders

On January 27, 2021, the Food and Drug Administration held its second webinar since the enactment of the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) in March 2020, to further ...
JD Supra

The Room Where It Happens: FDA Issues Draft Guidance on Formal Meetings Between FDA and Sponsors of OTC Monograph Drugs

In the original Broadway show Hamilton, Leslie Odom, Jr. sang, “I want to be in the room where it happens.” The Food and Drug Administration let sponsors and requestors of over-the-counter (“OTC”) ...