Mastering the Monograph Reform: Addressing Implementation Phase Challenges and Navigating Recent New FDA Guidances

January 23, 2024 10:30am

Ludjane Carvalho
Director Regulatory Affairs

Heidi Gertner
Hogan Lovells LLP

John F. Johnson III
Senior Counsel
Shook, Hardy & Bacon L.L.P

The OTC industry has undergone substantial transformations in recent years following the Monograph Reform mandated by the CARES Act. With new guidance recently coming out from the FDA, this panel will analyze the industry’s response to the new framework as well as implementation considerations and challenges.  Topics of discussion include:

  • Examining FDA’s recently released guidance impacting the preparation and submission of OMORs
  • Updates on the latest implementation activity, timelines and status of FDA meetings with industry
  • Evaluating the advantages of opting for an OMOR vs. NDA submission and exploring market exclusivity strategies for each approach
  • Assessing the industry’s response to the monograph reform
    • Have the new ingredient submission fees influenced innovation within the OTC space?
  • OMUFA Part 2: Forecasting potential changes to the Reauthorized OTC Monograph Drug User Fee Program
    • Examining what progress is being made in negotiations with Congress for the reauthorization of the OMUFA: what has been happening behind the scenes, what does the negotiation process currently look like and where do things currently stand?
    • Understanding the role of FDA and industry stakeholders in this process, and forecasting what changes may occur with the law