As with most pilot programs, participation is on a voluntary basis, and open to application holders of drugs with REMS. With the program, FDA intends to “evaluate a potential approach to converting REMS into SPL format and evaluate the usefulness of the REMS information to be provided in SPL format.”
FDA is accepting requests from candidates that meet the qualifications and are interested in participating until December 7, 2015. The program will last for four months, and will take place from October 6, 2015 to February 3, 2016. For more details on the program or how to register, see the announcement in the Federal Register, here.
This pilot program is one of FDA’s four “priority projects,” which were introduced in a July 2013 meeting in an attempt to improve the REMS program.
For the last 35 years, we have been helping our clients achieve successful interactions with the FDA and have established a strong relationship with the Agency over the years. We have the knowledge and experience you need to develop and submit a successful application. Contact us today to learn more about our services and how we can help you.