FDA recently announced changes to the Over-the-Counter (OTC) Monograph drug listings. As of October 1, 2023, the OTC monograph-related SPL values for "Marketing Category" and "Application Field" will transition to reflect values that correspond to the OTC monograph system as updated by the CARES Act and codified in section 505G of the Federal Food, Drug & Cosmetic (FD&C) Act.
On Wednesday, October 18, 2023, Reed Tech presented a webinar explaining these OTC Monograph changes. Reed Tech subject-matter experts Gary Saner and Caitlin Lynes help industry understand what these CARES Act-related changes mean for the OTC industry and how to navigate them through the year-end updates period.
Key Topics:
- Overview of OTC Monograph Changes
- How to make changes in SPL
- Timeline of OTC Monograph Changes
- Live Q+A
For more information about OTC Monograph Changes or MoCRA, visit our resource pages: Reed Tech.
Speakers:
Caitlin Lynes, Reed Tech
Gary Saner, Reed Tech
More questions? Contact pharma@reedtech.com or +1-215-557-3010.
About LexisNexis Reed Tech
LexisNexis Reed Tech brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our Reed Tech suite of SingleSource™️ for Medical Devices, SingleSource™️ for Drug Products, and Navigator™️ for Drug Labels enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind.
For more information, please visit ReedTech.com
