On December 13, 2016, the 21st Century Cures Act was signed into law with the intention of speeding FDA’s approval time for drugs and medical devices. When signed, the Cures Act increased FDA’s authority in a variety of areas. It also created a number of new mandates that the Agency is required to comply with, one of which mandated FDA to “publish a list of surrogate endpoints (SEs) used as a basis to approve or license a drug or biological product under both accelerated and traditional approval provisions.” The list, which was published on July 25, 2018, “fulfills the legislative requirement and is intended to provide valuable information for drug developers on endpoints that may be considered and discussed with FDA for individual development programs.”
SEs that may be appropriate for use as a primary efficacy clinical trial endpoint for drug or biologic approval (although the SEs have not necessarily been used to support and approved NDA or BLA)
FDA believes the table “should facilitate discussions of potential SEs by sponsors when developers are designing their drug development programs.” In addition to the SE table, the FDA’s accompanying webpage also explains the purpose of the table and provides additional background information.
On Tuesday, October 30th FDA published a notice in the Federal Register seeking comments and suggestions from the public. The Agency plans to use the feedback to:
Help determine the utility of the SE table
Develop future iterations of the SE table
Identify the best methods for conveying information on the Agency’s website
The Agency is asking that all interested parties submit written and electronic comments by December 31, 2018.
Are you in the process of preparing an NDA or BLA for submission to the FDA? This SE table could assist with the development of your application. We can help you develop and submit your application to the FDA, helping you maximize your chance of success with the Agency. Contact us today to learn more about our services and how we can help you.
On Wednesday, March 30th, FDA approved a new label for Mifeprex® (mifepristone), the medical abortion pill. The FDA stated that the drug is both safe and effective when taken in lower doses and up to...