The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), is pleased to announce the next webinar in our series.
On August 24, 2016, CDER hosted a LIVE webinar titled: Submitting Risk Evaluation and Mitigation Strategies (REMS) in Structured Product Labeling (SPL) Format: What You Need to Know
This 60 minute webinar provided information regarding the FDA’s new capability of receiving REMS data in SPL format. This project is a direct result of requests from industry and health care providers for more standardization in REMS programs. It also meets a commitment under the Prescription Drug User Fee Act to carry out certain priority projects to standardize REMS.
Specifically, the presentation addressed topics such as:
- Why submit REMS data in SPL?
- How to submit REMS data in SPL?
- Where to find helpful resources.
- Tips for successful submissions.
The featured speakers were:
Operations Research Analyst, Economics Staff
Office of Strategic Programs | CDER
Project Specialist, Drug Safety Operations
Office of the Center Director | CDER
The CDER SBIA webinars focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.
This event has been pre-approved by RAPS as eligible for up to 1 credit towards a participant’s RAC recertification upon full completion.
- REMS SPL Support: FDAREMSWebsite@fda.hhs.gov
For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707
- Introduction to REMS
- The REMS@FDA webpage
- Structured Product Labeling (SPL) Implementation Guide with Validation Procedures
- The FDAâs REMS Integration Initiative
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