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Read our public docket submission to FDA on REMS for Certain Opioid Drugs, including our RxFMEA analysis

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The New World of REMS...
Dear Colleague,

ParagonRx has helped to shape pharmaceutical risk management with innovative resources such as our two seminal books on the topic, science-based methods such as RxFMEA®, and the expertise gained from the wide ranging number of REMS and risk mitigation programs we've designed. Our science-based approached to risk management and REMS, as well as our ability to bridge medical and marketing perspectives is unmatched.

Today, we are happy to announce the launch of our new website, paragonrx.com. The site has been updated to provide you with new resources that are invaluable for anyone supporting appropriate use of medications and/or REMS.  Of particular interest is the REMS Hub, a resource center designed with input from risk managers in pharmaceutical companies like yours.

In this edition of our newsletter we highlight some selected important topics and insights featured on the website.

We hope you'll spread the word about our website, newsletter and blog. Also, please visit the REMS Hub,

In addition to subscribing to our RSS feeds, you can follow us on Twitter (@paragonrx).

Regards,

Jeff Fetterman, CEO

Gary Slatko, CMO


Ten of the most important considerations to take into account when developing a REMS:
1. Patient Safety First
2. Create Options
3. Co-design with Stakeholders
4. Use Science-Based Approaches

The REMS Directory is a comprehensive listing of factual information about REMS programs that have been required and approved by the FDA, with relevant information about the product for which the REMS was required.
globe in hand
Today we want to focus on key lessons learned from our clients' experiences. We are very grateful to these clients for allowing us to share their experiences with you so that you can do a better job in your REMS process....
We truely hope you appreciate everything.

Sincerely,

ParagonRx




 
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