FDA Reminds Industry to Submit Information for PDUFA Invoices

Drugmakers have until June 20 to submit information to the FDA needed to prepare fiscal 2017 PDUFA invoices.

The agency issued “Dear Colleague” letters to drugmakers on May 5, which include two attachments, reminding drugmakers to submit contact information and products and establishments subject to PDUFA user fees. Information about the letters was posted on the agency’s website last week.