The recent LexisNexis Read Tech webinar, Comply with Pharma Year-End Deadlines: 2024 Mandate Updates, provided a comprehensive overview of the FDA’s year-end submission requirements for drug manufacturers. The session featured insights from Andrew Ethridge, Rachel Finley and Gary Saner, all subject-matter experts from the LexisNexis Read Tech Life Sciences team.
The webinar began with an introduction to the annual FDA deadlines, emphasizing the importance of understanding the year-end Q4 requirements. Key topics included the 2024 updates, drug data storage and management options and additional listing updates.
Gary Saner first provided an overview of the annual calendar for FDA drug deadlines, highlighting the importance of establishment registration and drug label listing. He emphasized the need for timely submissions to avoid being marked as expired by the FDA, which could result in misbranding. Rachel Finley then discussed the 2024 updates, particularly for over-the-counter drug products. She explained the transition from outdated monograph categories to a new OTC monograph drug category and the importance of updating product listings accordingly. Andrew Ethridge elaborated on the validation checks for combination product types, ensuring accurate identification in drug listings. The webinar also addressed common errors in blanket no change certifications, such as establishment registration issues and outdated OTC monograph information. Rachel emphasized the importance of verifying establishment registrations and avoiding the inclusion of uncertified or inactive NDC codes in submissions.
Andrew introduced the Reed Tech solution for managing SPL information, highlighting the benefits of a secure, validated environment for compliance submissions. He explained how the technology facilitates efficient data management and supports global market submissions. Gary concluded with industry updates, including the expiration of the hand sanitizer manufacturing exclusion from the OMUFA facility fee and the US CARES Act reporting requirements. He also touched on the Modernization of Cosmetic Regulation Act (MoCRA) and Health Canada’s XML product monograph initiative.
The webinar provided valuable insights into navigating the complex landscape of FDA submissions, emphasizing the importance of timely and accurate compliance to avoid potential pitfalls. Good news, if you were not able to attend, you can watch a recording now!
We encourage you to reach out to LexisNexis Read Tech for further assistance and to explore our comprehensive suite of services for regulatory compliance: [email protected] or +1 (215) 557-3010.