Approval Pending: How to Plan for PDUFA Decisions

Over the past 40 years, the FDA has approved an average of 31 new drugs annually. The number has continued to increase since the Prescription Drug User Fee Act (PDUFA) was approved.¹ As new drugs continue to proliferate, planning for FDA approval is an essential, multidisciplinary process.

Prescription Drug User Fee Act

PDUFA was approved in 1992. It allows the FDA to collect fees from drug companies in exchange for committing to a clear timeline for approval decisions.² PDUFA was created to address the backlog of new drug applications awaiting FDA review. The approval of PDUFA has provided clarity to drug companies and accelerated the approval process. Prior to PDUFA’s enactment, the average time to drug approval was almost 2 years. Now the average time to approval is 10 months for standard review and 8 months for priority review applications.³ PDUFA requires reauthorization every 5 years, with the most recent version (PDUFA VII) signed into law in 2022.⁴

Once the FDA accepts a new drug application (NDA) for review, the agency has 6 to 10 months to review it and reach a decision. The end of this review period is often referred to as the PDUFA date. This date is not guaranteed, and the agency may request an extension, which may require additional data before approval.⁵

On or before the PDUFA date, the FDA will either approve the NDA, issue a complete response letter (CRL), or deny the NDA. A CRL is issued when the application cannot be approved in its current state, typically due to safety, efficacy, or manufacturing concerns.⁶ Once the drug sponsor addresses deficiencies, the application may be resubmitted, and a new review timeline and PDUFA date will be provided. For example, the approval of odronextamab (Ordspono; Regeneron Pharmaceuticals, Inc) was paused after the FDA issued a CRL due to issues identified during the manufacturing site inspection; this was the second CRL issued for odronextamab, with a previous CRL related to confirmatory trial enrollment.⁷ Although drug availability does not occur until after approval, planning can begin much earlier than the PDUFA date.

Planning for Drug Approval

Early planning allows for the identification of barriers to implementation, creation of staff training, and potentially quicker access to potentially lifesaving medications for patients. Planning is a multidisciplinary process often involving physicians, clinical pharmacists, pharmacy leadership, information technology, and supply chain personnel.

Close monitoring of upcoming drug approvals can facilitate a smoother transition after approval and enable pharmacists to provide patients with the most up-to-date information. Although the FDA does not publish a list of expected PDUFA dates, drug sponsors often publish their own expected action dates. Alternatively, third-party sites publish expected action dates and often compile them in a calendar format, making it a convenient way to track PDUFA dates.⁸ Communication regarding PDUFA dates should also be tracked internally. Consider an internal tracking system that includes key stakeholders and frontline staff to ensure consistent information is shared about new drugs and their expected use.

While drugs are awaiting approval, clinical evaluation can begin based on available literature. In collaboration with physicians, pharmacy leadership can determine expected usage and the drug’s place in therapy. Drafting a preliminary skeleton drug monograph can help prepare for pharmacy and therapeutics (P&T) committee meetings and expedite the formulary process. All necessary information, such as expected costs, will not be available until after approval, but prepping in advance helps ensure a smoother transition afterward.⁹

One area of evaluation leading up to the approval date should be the location of administration (ie, inpatient or outpatient). Factors such as length of administration, required monitoring, and expected adverse events may influence the location. These decisions can affect nursing, chair time, and reimbursement. Once these decisions are made, work with nursing leaders to develop appropriate workflows and education, either prior to approval or shortly after, to ensure a smooth transition.¹⁰ 

The final area to evaluate involves the needs of the electronic medical record and the impact on the supply chain. Working with information technology staff will enable safe prescribing of the new medications and ensure appropriate safeguards are entered in the electronic order. Although real-time entry is unlikely to go live until after P&T approval, prior planning can help identify potential barriers.⁹ Finally, supply chain impacts can be evaluated once the drug is added to the formulary. Identifying a potentially limited distribution specialty medication or noting that the new drug is expected to have a Risk Evaluation and Mitigation Strategy program should be communicated to the appropriate stakeholders.

Final Thoughts

With the increasing number of drug approvals over the past several years, planning for approval is key to a successful rollout. Evaluation of clinical data, updates to the electronic medical record, and collaboration with key supply chain stakeholders can enable quick access to lifesaving medications for patients.

REFERENCES

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2. Winslow G. Navigating the path to FDA approval: the importance of a PDUFA date. Halloran. March 22, 2024. Accessed August 28, 2025. https://hallorancg.com/insights/2024/03/22/navigating-the-path-to-fda-approval-the-importance-of-a-pdufa-date

3. PDUFA. PhRMA. Updated March 2023. Accessed August 28, 2025. https://phrma.org/policy-issues/research-development/pdufa

4. PDUFA VII: fiscal years 2023-2027. FDA. Updated April 24, 2023. Accessed August 28, 2025. https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027

5. Speights K. What is a PDUFA date? Motley Fool. Updated July 3, 2025. Accessed August 28, 2025. https://www.fool.com/terms/p/pdufa-date/?msockid=36462706ad9264743efd3372ac80656b

6. Wahner A. FDA release CRLs for previous drug and biologic product applications. OncLive. July 10, 2025. Accessed August 28, 2025. https://www.onclive.com/view/fda-releases-crls-for-previous-drug-and-biologic-product-applications

7. Wahner A. FDA issues CRL for odronextamab in relapsed/refractory follicular lymphoma. OncLive. August 1, 2025. Accessed August 28, 2025. https://www.onclive.com/view/fda-issues-crl-for-odronextamab-in-relapsed-refractory-follicular-lymphoma

8. Standard FDA calendar. FDA Tracker. Accessed August 28, 2025. https://www.fdatracker.com/fda-calendar/

9. Ciccarello C, Leber MB, Leonard MC, et al. ASHP guidelines on the Pharmacy and Therapeutics Committee and the formulary system. Am J Health-Syst Pharm. 2021;78(10):907-918. doi:10.1093/ajhp/zxab080

10. Wood T. Managing treatment with new and expensive drugs: what pharmacy leaders need to know. Pharmacy Times. September 16, 2024. Accessed August 28, 2025. https://www.pharmacytimes.com/view/managing-treatment-with-new-and-expensive-drugs-what-pharmacy-leaders-need-to-know