There are two regulatory pathways to bring a nonprescription drug to market in the United States: the drug application process and the Over-the-Counter (OTC) Drug Monograph process. This webinar, featuring MMS’s Ritchie Patton, MBA, with insights from Dr. Jay Sirois, Vice President of Regulatory and Scientific Affairs at the Consumer Healthcare Products Association, will review principles of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, signed into law in 2020, which reformed and modernized the framework for the regulation of OTC monograph drugs.
A new administrative order process (Section 505G(b) of the FD&C Act) allows the industry or FDA to initiate a process to add, remove, or change generally recognized as safe (GRASE) conditions for an OTC drug monograph.
In this Fireside Chat hosted by MMS, you will learn about the different types of OMORs and how an OMOR differs from a New Drug Application (NDA). We will also discuss how to interact with the FDA during the OMOR process to maximize helpful feedback and provide an overview of the FDA processes outlined in Guidance regarding OMOR formats, content, timing, and submission packages.
Watch this Webinar to:
- Learn directly from industry leaders who bring deep expertise in navigating the complexities of U.S. regulatory pathways for nonprescription drugs.
- Get up-to-date on the significant reforms brought by the CARES Act, including the new administrative order process (OMOR), and how these changes impact the OTC drug approval process.
- Discover strategies for effectively engaging with the FDA during the OMOR process to optimize feedback and improve your chances of successful submissions.
What You Will Learn:
- Understand what an Over-the-Counter Monograph Order Request (OMOR) is and how it plays a crucial role in modernizing OTC drug regulation under the CARES Act. Discover the key differences between an OMOR and a New Drug Application (NDA), and understand which pathway is appropriate for your nonprescription drug. Gain practical tips on how to effectively engage with the FDA during the initial planning stages of an OMOR to ensure productive feedback and smooth submission processes.
Who Will Benefit from Attending?
- Regulatory affairs professionals involved in drug approval processes who need to stay informed about the latest regulatory changes and pathways for nonprescription drugs.
- Pharmaceutical and OTC drug manufacturers looking to navigate the complexities of the U.S. regulatory landscape for bringing nonprescription drugs to market.
- Healthcare and compliance specialists responsible for ensuring that products meet FDA regulations.