FDA to publish CRLs ‘promptly’ as drugs are rejected

The US Food and Drug Administration (FDA) on Thursday announced it will publish complete response letters (CRLs) detailing the reasons for a product’s rejection soon after they are issued to drugmakers. Alongside the announcement, the agency released a batch of 89 CRLs for products that have been rejected since 2024 and are no longer being pursued by their sponsors.

Both actions are part of the agency's efforts to promote "radical transparency" and clarify the reasons behind the rejection of certain drugs. However, one attorney expressed concerns that this approach may violate the agency's own regulations regarding disclosure.

The agency’s recent action is more comprehensive than its July announcement, which included the publication of 200 letters for approved drugs only. In this case, FDA also released complete response letters for rejected applications. (RELATED: FDA publishes 200 complete response letters in transparency effort, Regulatory Focus 10 July 2025)

“Going forward, the agency will promptly release newly issued CRLs, and when approving applications will release all CRLs associated with that application,” FDA announced.

This action is significant because, traditionally, FDA does not publish CRLs at the time they are issued; these letters are usually released only after a drug is approved.

The agency primarily issues CRLs due to concerns about safety and efficacy and manufacturing deficiencies. The CRLs specifies what the sponsor must do to resolve the deficiencies listed in the letter before the product can be approved.

“This is a milestone day for the agency,” announced FDA Commissioner Marty Makary. “By embracing radical transparency—one of the guiding principles of this administration—we’re giving invaluable insights to help speed therapies and cures to market, providing complete context to investors and shareholders, and above all, restoring public trust.”

The agency also said it plans to publish additional batches of previously issued CRLs related to withdrawn or abandoned applications.

“Publishing CRLs offers important benefits for public health, including empowering drug developers to avoid common missteps and efficiently bring more cures and meaningful treatments to the American public; delivering greater insight to patients and the health care providers who treat them; and ensuring sponsors provide complete and contextualized information in communications to investors and shareholders,” FDA said.

The letters are now available on the agency’s openFDA resource; previously, the published letters were only available by navigating to a specific drug in the agency’s Drugs@FDA database and viewing the review documentation for that product.

FDA said all CRLs will be redacted to remove confidential commercial information, trade secrets, and personal private information, but will contain company names.

Even though FDA announced that proprietary information will be redacted from unapproved applications, Rachel Turow, an attorney with Skadden, Arps, Slate, Meagher & Flom raised concerns that this action to publicly disclose CRLs for drugs and biologics runs afoul of the agency’s regulations under 21 CFR 314.430.

She added that this action “raises the possibility of litigation because [the action] strays so far from the regulations.”

Turow said that publishing a CRL would involve acknowledging the existence of an unapproved application, which has not been FDA’s standard practice.

The regulation under 21 CFR 430 states that “FDA will not publicly disclose the existence of an application or abbreviated application before an approval letter is sent to the applicant under Section 314.105 or tentative approval letter is sent to the applicant under Section 314.107 unless the existence of the application or abbreviated application has been previously publicly disclosed or acknowledged.”

The archive contains 89 CRLs issued since 2024, including recent CRLs sent to Replimune for its biologics license application (BLA) for vusolimogene oderparepvec for advanced melanoma and to Capricor for its BLA for deramiocel to treat Duchenne muscular dystrophy.

Announcement; OpenFDA

FDA to publish CRLs ‘promptly’ as drugs are rejected

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