For an original NDA, whether it is a 505(b)(1) or 505(b)(2), there is a PDUFA fee to be paid at the time of the submission of the application or the FDA will refuse to file it. For a small business ( a company of less than 500 employees) the fee can be waived for its first NDA. However, the submission must be accompanied by an approved waiver. At this writing, the waivers are taking over 2 months to process at the FDA. Most companies cannot afford to submit with a big check and wait for the refund when the waiver is approved. This means that you should get your waiver request in at least 3 months before your planned filing date. More PDUFA fee information is available on the FDA website.
Although FDA has, in the past, accepted an NDA and waited for the ‘check to clear’, there has been an abuse of the system and FDA Divisions that we are working with have generally decided that the waivers or checks must be submitted at the time of the application.