How to Comply with the FDA Submission Requirement

Wednesday, April 20th at 2 PM ET

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Register to view the recording for the REMS in SPL: How to Comply with the FDA Submission Requirement webinar. 

After a very long road, industry is now fast approaching the required submission deadline, December 28, 2022, for Risk Evaluation and Mitigation Strategy (REMS) in Structured Product Labeling (SPL) format. While participation is currently voluntary, and has been since September 2016, compliance with this guidance will be required as per the final guidance issued December 2020.

In this webinar, Reed Tech subject-matter experts, Gary Saner and David Wilson, discussed the structured format requirements for REMS to help regulatory experts understand what the final guidance includes, what actions are required of you and the deadlines surrounding these activities. The speakers help explain how this move to structured content will increase access and ease of use for all REMS content stakeholders including sponsors, FDA, Providers, prescribers and patients.

Key Topics

  • REMS in SPL Initiative
  • REMS in SPL Implementation
  • REMS in SPL Solutions
  • Q & A

Register now to view the recording for the webinar and to download the slide deck!

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Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry's data. Our offerings smooth the collection, transformation, submission and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.