CDER Right-to-Try Summaries Can Go Thru Portal

CDER says it is updating its CDER NextGen Portal to allow Right to Try annual summary submissions for CDER-regulated drugs and biological products. “The manufacturer or sponsor of a CDER-regulated drug or biological product provided under Right to Try should now submit its annual summary through the portal," according to a notice. Submitters should continue to use Form FDA-5023, which can be uploaded to the portal. Annual summaries are due by 3/31 for any use of eligible investigational drugs under the Right to Try Act during the previous calendar year, FDA says.

The portal is said to improve and streamline the electronic submission process, and it provides a confirmation that a submission has been successfully received by CDER. Additionally, the portal will share the submission with other CDER regulatory review systems.

FDA notes that Right-to-Try submissions for CBER-regulated biological should continue to be submitted to RTTAnnualReports@fda.hhs.gov.