• Provision Consulting Group

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar


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

https://events-na12.adobeconnect.com/content/connect/c1/1315899612/en/events/event/shared/2535253967/event_registration.html?sco-id=3871423581&_charset_=utf-8


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.


https://www.fda.gov/drugs/news-events-human-drugs/otc-monograph-drug-user-fee-program-omufa-understanding-fy-2021-user-fees-webinar-06032021-06032021