Navigating FDA User Fee Updates for Fiscal Year 2023

As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs (including small molecules, vaccines, cell and gene therapy products, biologics, etc.), Generic Drugs, Biosimilars, and Medical Devices. In this context, ProPharma would like to bring attention to these updates for our clients, colleagues, and contacts.

Given that most user fee updates entail fee increases, now is an opportune time for all FDA-regulated companies to assess their eligibility for user fee waivers or discounts. A common example: drug sponsors with FDA Orphan Drug Designations qualify for a PDUFA fee waiver. Specifically, NDAs (New Drug Application) and BLAs (Biologics License Applications) associated with development programs that have received Orphan Drug Designations are exempt from PDUFA fees unless the NDA/BLA includes an indication other than the rare disease or condition addressed in the Designation. To be eligible for the exemption, the drug sponsor must also have received less than $50 million in gross worldwide revenue during the year prior to requesting for the exemption. It's important to note that this represents just one instance among several potential opportunities for fee waivers and discounts, all of which merit consideration. The table below summarizes some of the key fee updates for Fiscal Year 2023.

To summarize:

Fiscal Year 2023 introduces varied changes in FDA User Fees, reflecting the dynamic landscape of the pharmaceutical, biologics, and medical device domains. Staying well-informed is paramount for industry professionals and organizations as they navigate these financial adjustments. As the FDA continues to prioritize healthcare product safety and efficacy, user fees remain essential in supporting these endeavors.

For precise insights into how these fee changes may affect your organization or submissions, consult the official FDA guidance and regulatory experts. ProPharma, leveraging its extensive regulatory expertise, stands ready to assist you in comprehending the updated fee structure and crafting strategies that seamlessly adapt to these changes. Our collective efforts ensure that the FDA can continue to fulfill its crucial mission of safeguarding public health while fostering innovation in the ever-evolving healthcare sector.

Take proactive steps today; contact ProPharma for personalized guidance and stay ahead of the curve.