Business · 27/08/2012
FDA Offers Opportunity to Withdraw Pending ANDA Applications to Avoid Backlog Fee
The FDA is providing a deadline for applicants to withdraw their pending original abbreviated new drug applications (ANDAs) by October 1, 2012, to avoid a one-time backlog fee established by the Generic Drug User Fee Amendments of 2012 (GDUFA).
Original source language: Federal Register — Food and Drug AdministrationOpen original release →