Brian Malkin Comments on ANDA Bolus with Upcoming Fee Hike

Beginning October 1, 2017, ANDA user fees will jump in price. If an ANDA is submitted on September 30, the price is just over $70,000. Submitting a day later on October 1 will cost nearly $172,000.

This has led to questions within the industry on whether a rush of sponsors pushing to submit before the significant rate increase. According to Pink Sheet there has not been an ANDA bolus as of yet. Arent Fox FDA counsel Brian Malkin spoke with Pink Sheet, noting that the pending fee increase is “an incentive for more submissions before October 1, but…it does not make send to send an application before it is ready and risk a refuse-to-receive action.”


Continue Reading