FDAnews Announces — What You Need to Know: OTC Drug Reform & the CARES Act (Monographs & OMUFA) Webinar Sponsored by Reed Tech Oct. 21, 2020

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OTC Monograph Reform guidelines are becoming clearer. Get answers through this free webinar.



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 free webinar can help one understand the next steps.

Through our experts, attendees will find out whether these changes will impact you and how one can navigate the shifts with expertise and savvy.

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 an 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 questions about how these requirements may impact a business.

We will cover:

The FDA’s OTC Monograph Reform, OMUFA, and OMOR

  • Understanding OTC Monograph Order Requests
  • The effect on existing OTC products
  • The impact on private label distributors
  • Examples of impacted products: hand sanitizers, sunscreens, topical analgesics, and CBD-infused products

OMUFA and the Coronavirus Aid, Relief, and Economic Security (CARES) Act

  • The consequences of the COVID-19 pandemic
  • Required user fees for all OTC drug manufacturers, similar to the Generic Drug User Fee and the Prescription Drug User Fee

Suggested Best Practices

  • Complying with the FDA’s new OTC regulatory framework
  • Advantages of a comprehensive, global strategy for regulatory compliance

Opportunities for Innovation

  • Exclusivity for OTC drug products

Working to expand the team’s OTC product manufacturing? 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 the team grow and succeed.

Webinar Details:
What You Need to Know:
OTC Drug Reform & the CARES Act (Monographs & OMUFA)
A Free FDAnews Webinar Sponsored by Reed Tech
Wednesday, Oct. 21, 2020, 11 a.m. – 12:00 p.m. EDT

Easy Ways to Register:
Online: http://info.fdanews.com/what-you-need-to-know? free_webinar_source=HP
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
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