The FDA announced plans to add more than 1,000 staffers and launched a pilot communications program that allows sponsors to submit one brief email clarification to Office of New Drugs review staff after meetings, with promised responses within three business days. The hiring push targets reviewers, inspectors and mission‑critical roles to bolster review capacity. FDA Commissioner Marty Makary framed the email pilot as a time‑saving measure for sponsors, designed to reduce months of uncertainty and speed development pathways. The agency said early users already found the program helpful for resolving technical questions arising from meeting minutes. Critics and former officials have flagged workforce churn and prior hiring shortfalls; the new hires and pilot communication channel are positioned as corrective steps to stabilize review timelines and reduce needless delay for developers.
Get the Daily Brief