Increasing Speed & Accuracy of Remote Audits with Modern Cloud QMS

A Free FDAnews Webinar • Sponsored by Veeva Systems
Thursday, Dec. 17, 2020 • 11:00 a.m. - 12:00 p.m. EST

Requirements around the OTC Monograph Reform, the Over-the-Counter Monograph User Fee Program (OMUFA), and the OTC Monograph Order Requests (OMORs) are about to become clearer. The FDA is expected to release additional guidance soon — and this FDAnews webinar can help you understand the next steps.

One particular change: With the passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act in March 2020, it is likely that all OTC drug manufacturers will need to pay a user fee, similar to those established under the Generic Drug User Fee (GDUFA) and Prescription Drug User Fee (PDUFA). The Act will also create new opportunities for innovation and help finalize the large number of pending monographs in many of the OTC drug therapeutic categories.

During this detailed conversation, medical device identification expert Gary Saner will speak with regulatory attorney Carolina M. Wirth about opportunities for growing your OTC portfolio and the complicated compliance issues that may arise during that effort. The pair will discuss OTC monograph reform, provide clarity on the industry’s current regulatory expectations and answer your questions about how these requirements may impact you.

We will cover:

  • The FDA’s OTC Monograph Reform, OMUFA, and OMOR
    1. Understanding OTC Monograph Order Requests
    2. The effect on existing OTC products
    3. The impact on private label distributors
    4. Examples of impacted products: hand sanitizers, sunscreens, topical analgesics, and CBD-infused products
  • OMUFA and the Coronavirus Aid, Relief, and Economic Security (CARES) Act
    1. The consequences of the COVID-19 pandemic
    2. Required user fees for all OTC drug manufacturers, similar to the Generic Drug User Fee and the Prescription Drug User Fee
  • Suggested Best Practices
    1. Complying with the FDA’s new OTC regulatory framework
    2. Advantages of a comprehensive, global strategy for regulatory compliance
  • Opportunities for Innovation
    1. Exclusivity for OTC drug products

Are you working to expand your team’s OTC product manufacturing? Do you currently have pharmaceutical products that may be impacted by these shifting regulations? This free webinar will explain the expectations and possibilities of the adjusted OTC Monograph Reform coming our way.

Join us for expert insights to help your team grow and succeed.

Who Will Benefit

  • Global strategy business managers
  • Regulatory affairs and operations leaders
  • Product managers
  • Business analysts
  • Manufacturing, operations, and supply chain leaders
  • Quality leaders
  • IT support professionals

Sign Up for FREE Below

Meet Your Presenters


Gary Saner

Sr. Manager, Information Solutions-Life Sciences
Reed Tech

Gary Saner, this webinar’s host, is an expert on medical device unique device identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in software development, process management, and data administration, focusing the last 15 years on the life science industry. He serves as co-chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.


Carolina M. Wirth

Of Counsel
Arnall Golden Gregory LLP

Carolina M. Wirth, this webinar’s guest speaker, is Of Counsel at Arnall Golden Gregory LLP. She is a member of the firm’s Food & Drug Practice and of the Dietary Supplements and Pharmaceuticals & Biologics Industry Teams. Her practice focuses on providing domestic and international clients with FDA regulatory guidance on issues associated with the approval, marketing, labeling, packaging, and advertising of conventional foods, prescription, and over-the-counter (OTC) drugs, medical devices, cosmetics, and dietary supplements. Wirth’s prior experience includes serving as regulatory counsel in the Office of Regulatory Policy in the FDA’s Center for Drug Evaluation and Research.