Resources

Risk Evaluation and Mitigation Strategies (REMS) industry professionals are essential participants in moving the industry forward and bolstering patient safety and positive outcomes. Through research, innovation, and experience, REMS professionals contribute to advancing best practices in the development and regulation of new drugs and biologics. The REMS Industry Consortium (RIC) has dedicated this portion of the site to resources specifically tailored to REMS industry professionals. 

Return to this space for updated information as resources are developed for the exclusive use of RIC members.

FDA VIRTUAL MEETING

The FDA is hosting a virtual meeting on "Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation" on November 7th from 1:00 pm to 2:30 pm Eastern. For more information, please visit the FDA website.

REMS Journey Brochure

RIC's REMS Journey Brochure maps out each and every step of the REMS process. Check it out and see where your journey will take you.

The Value of RIC Membership - Why Join? 

See the RIC’s "Value of Membership" presentation. This information can be used as a conversation starter, an informative leave behind, or added to presentations you may be giving in the future and want to take the opportunity to incorporate the RIC.

REMS 101 Course

We are excited to announce the launch of the RIC’s REMS 101 course. The REMS 101 course was developed by REMS Industry Professionals on the RIC as a tool to be used by professionals to learn about REMS. Click here to download.

FDA News, Updates and Resources

The REMS Industry Consortium aims to assist all members of the REMS community with staying informed about drug safety with valuable insights from the FDA, including updates on recalls, safety alerts, and other essential information and resources.  The links to these FDA resources should prove to be beneficial to your Risk Evaluation and Mitigation Strategies and facilitate you on your REMS journey.

RIC Comments to FDA Docket No. FDA-2023-N-0573 on "Changes to Third-Party Vendors"

On behalf of the RIC membership, official comments were submitted to the FDA regarding Docket No. FDA-2023-N-0573. To read full comments, click here.

FDA 7th Annual Drug Safety Priorities Report

The FDA recently published its 7th Annual Drug Safety Priorities Report with multiple references to REMS improvements and resources. 

RIC Introduction Letter

See the RIC’s letter of introduction to the FDA here. Share this update with contacts in your network to introduce RIC to your peers!

Understanding The FDA's Current Focus On Risk Evaluation And Mitigation Strategies
This article was originally published in Life Science Connect publications on September 21, 2023.