FDA User Fee Programs: Congress Contemplates a Clean Reauthorization in the Continuing Resolution
By EsqSocial Corporation 23/09/22
The Food and Drug Administration’s (FDA) user fee programs, which pay the salaries of agency staff who review drug and medical device applications, are set to expire on October 1, 2022. These include the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Amendments (MDUFA)....
By: Foley & Lardner LLP