Fewer PMA Approvals In FY 1998 Anticipated By Device Center's Alpert
This article was originally published in The Gray Sheet
FDA expects to approve fewer than 40 original premarket approval applications in fiscal year 1998 (ending Sept. 30), down from the prior "banner year" in which the agency okayed 48, Office of Device Evaluation Director Susan Alpert forecast at a recent Food and Drug Law Institute meeting in Washington, D.C.
You may also be interested in...
Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.
However, Vaccinex sees possible efficacy for SEMA4D inhibition in later-stage Huntington’s as well as Alzheimer’s disease. Pepinemab is also being studied with Keytruda in head-and-neck cancer.
In last year’s acquisition, Bristol Myers Squibb agreed to pay Celgene investors another $9 per share based on three approvals, including idecabtagene vicleucel (bb2121) by 30 March 2021.