The FDA is experiencing rising delays in drug approvals, raising concerns about operational strain within the agency, according to an RBC Capital Markets analysis. The Oct. 20 report, which was shared with Becker’s, found a sharp increase in missed action dates and complete response letters during the third quarter of 2025. While the agency’s permissiveness rate remains what the report calls “fair” in its approval decisions overall, mounting internal challenges, from staffing to inspections, could continue to push Prescription Drug User Fee Act timelines.
Here are five things to know:
- Approval delays surged in Q3: The FDA’s drug approval rate dropped to 73% in the third quarter of 2025, down from an average of about 87% in previous quarters. Complete response letters rose to 15% and missed PDUFA deadlines reached 11%, up from a 4% average.
- Recent delays may reflect systemic strain: RBC linked the rising delays to cumulative disruptions in FDA infrastructure, including short-staffing, leadership turnover and inspection backlogs — challenges that may be exacerbated by the ongoing government shutdown.
- Manufacturing-related complete response letters are increasing: Facility and manufacturing issues accounted for approximately 40% of CRLs in 2025, up from about 29% in 2024. A single site, Novo Nordisk’s Indiana plant, was linked to several recent CRLs, including those affecting Regeneron and Scholar Rock.
- Some disease areas are more affected than others: Applications in hematology and endocrine disorders saw the most delays, while oncology, cardiology and ophthalmology remained relatively stable or improved. Most delays originated from CDER, particularly among biologics and new molecular entities.
- Upcoming approvals may be at risk: PDUFA dates for several companies could be affected if delays continue, including filings from BioCryst (Orladeyo), Regeneron (Eylea HD), Cytokinetics (aficamten), Arrowhead (plozasiran) and Agios (Pyrukynd).
