Participants will benefit from attending this session through learnings from an expert panel presentation that highlights and summarizes the OTC Monograph Reform introduced in the March 27, 2020 CARES Act.
Monograph reform provides the Food and Drug Agency (FDA) with the statutory authority to reform and modernize the OTC Monograph System. The 50-year-old OTC Monograph system has not provided the Agency or Industry with the necessary tools, resources, financial support and structure needed to finalize or update the monograph system. The current monograph system has been unable to deliver safety updates in a timely manner or provide for innovation for ingredients.
The expert panel will provide the audience with a history on the background and limitations of the current monograph system, a summary and overview of the new regulatory pathways for safety updates, monograph GRASE finalization and discuss industry opportunities such as new innovation. The presentation will provide information for regulatory professionals on the new regulatory processes and requirements within the legislation. Additional topics to be discussed include opportunities for potential exclusivity provisions for innovation , a summary of the types of User Fees and a brief discussion of some of the new provisions in the reform. Finally, the presentation will provide summary highlight of the accompanying goals letter.
Summarize the limitations of the monograph system.
Describe or summarize the highlights of the CARES Act as it relates to OTC monograph reform.
Describe the types of monograph requests that industry would submit to the Agency.
Describe the regulatory status of category I, II and III ingredients.
Understand the process steps associated with requests to change or update the monograph and Agency responses.
Learn about new opportunities for industry to innovate under the monograph.
Understand the principles for obtaining exclusivity with innovation.
Understand the user fees associated with OTC Monograph reform.