Outsourcing Facilities See Nominal Rise in Fees in FY 2017
The FDA will raise the annual fees for outsourcing facilities and reinspections in fiscal 2017.
The agency announced that small business outsourcing facilities will shell out $5,279 — up just $76 — as part of their annual dues. Fees for larger outsourcers will see a more substantial climb, with the price rising $387 to $16,852.
The agency estimates seven facilities will qualify as small businesses and 65 will pay the fees for larger outsourcing facilities in the next fiscal year.
Reinspection fees for all outsourcing facilities will climb to $15,837, an increase of $227 uptick.
The price hikes take effect Oct. 1, following the trajectory of biosimilar user fees and some generic user fees in the next fiscal year, some of which also saw upswings.
The agency, however, lowered the user fees for prescription drug submissions, generic drug applications and supplemental filing.
Read the notice here: www.fdanews.com/07-29-16-FDAOutsourcingFacilityFees.pdf.
Managing and leading people through an FDA inspection is a combination of art and science. Master the process with the FDAnews DVD Inspection Preparation Training for Drugmakers.