FDA Incident Reporting Conference
This article was originally published in The Gray Sheet
Executive Summary
Agency meeting health professional organizations on May 4 in Washington, D.C. in preparation for a medical products incident reporting conference on June 3, FDA announces April 22 in the Federal Register. FDA is holding the "premeeting" to discuss steps the health organizations can take to inform members about the agency's reporting programs. The session will include a presentation by FDA Commissioner David Kessler of the agency's incident reporting educational plans. The June 3 conference will include discussion of a device/drug/biologic reporting form under development at the agency ("The Gray Sheet" April 19, p. 21).
You may also be interested in...
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.
Colorado Price Cap Plan For Enbrel Draws Amgen Lawsuit; Cosentyx, Stelara ‘Affordability’ Reviews Pending
However, the state's recently formed prescription drug affordability board found Gilead’s Genvoya and Vertex’s Trikafta to be affordable.