The questions regarding Over-The-Counter Monograph Drug User Fee from related establishments have been radically increasing. The FDA is planning to hold a webinar to resolve such issues. The FDA will provide an overview of the Over-The-Counter Monograph Drug User Fee Program (OMUFA) and describe the program's key elements as it relates to OMUFA user fees. Please find the information below.
Registration for the Webinar
Date & Time
June 3, 2021
1:00 PM - 2:00 PM ET
FDA SPEAKERS
CAPT Teresa Ramson, Pharm.D., MBA, RAC Deputy Director, Division of User Fee Management (DUFM) Office of Management (OM) | CDER | FDA
CAPT Matt Brancazio, Pharm.D., MBA, RAC Branch Chief, Policy and Operations Branch DUFM | OM | CDER | FDA
LCDR Tramara Dam, Pharm.D., GWCPM Program Management Officer, Policy and Operations Branch DUFM | OM | CDER | FDA
INTENDED AUDIENCE
Regulatory affairs professionals working on over-the-counter monograph drug products and/or non-prescription drugs or who submit over-the-counter monograph order requests
Industry partners following the FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program known as OMUFA
General public with an interest in over-the-counter monograph drug products and/or non-prescription drugs
Researchers testing over-the-counter monograph drug products and/or non-prescription drugs
Foreign regulators of over-the-counter monograph drug products and/or non-prescription drugs
Consultants focused on processing, manufacturing, developing of over-the-counter monograph drug products and/or non-prescription drugs
Clinical research coordinators
Healthcare professionals specializing in over-the-counter monograph drug products or non-prescription drugs
Importers of over-the-counter monograph drug products and/or non-prescription drugs
The supply chain of over-the-counter monograph drug products and/or non-prescription drugs
You may find detailed information here.