FDA Increases CRL openness: What Sponsors Need to Know
The US Food and Drug Administration (FDA) is considerably increasing transparency by publicly releasing Complete response Letters (CRLs). CRLs detail the reasons an application for a new drug or biologic is not yet approved, outlining deficiencies and recommended solutions. On September 4, 2025, the FDA announced the release of a second batch of 89 CRLs related to applications that were either pending or ultimately withdrawn – a departure from the initial release in July 2025, which focused on applications that were eventually approved. The FDA intends to continue publishing CRLs promptly after they are issued to sponsors, including those for withdrawn or abandoned applications.What to Expect with Publicly Released CRLs:
While the FDA is redacting CRLs to remove confidential commercial facts, trade secrets, and personal private information (as legally required), even redacted versions can reveal sensitive details. the FDA has not yet clarified how redactions are being applied, including whether its new AI tool, Elsa, is being utilized.
Regulatory Considerations & Potential Compliance Concerns:
The FDA acknowledges the regulations governing CRL disclosure. Though, questions remain about whether the agency has fully confirmed compliance with these regulations, particularly 21 C.F.R. § 314.430, which restricts the public disclosure of information from unapproved applications not previously acknowledged. It’s unclear how the FDA will balance its commitment to prompt CRL release with these existing regulations.
Impact for Product Sponsors:
This increased transparency presents meaningful implications for product sponsors. CRLs contain detailed, often technical, feedback on application weaknesses - information that could be leveraged by competitors to accelerate their own development strategies. Furthermore, publicly available CRLs could be used in litigation, including securities litigation for publicly traded companies.
In short, sponsors should prepare for a more obvious regulatory landscape and proactively assess the potential risks associated with the public release of their CRLs.
