The FDA last week confirmed that it would suspend the release of complete response letters pending the resolution of a citizen petition from an unnamed pharma company. Nevertheless, 14 new CRLs are now available on the agency’s portal.
Just days after it confirmed a temporary suspension to its public disclosure of complete response letters, the FDA seems to have uploaded another batch of such documents to its online portal.
The CRLs include one handed out July 9 rejecting Jiangsu Hengrui and Elevar Therapeutics’ application for a combination regimen of the PD-1 inhibitor camrelizumab and the VEGF blocker rivoceranib for hepatocellular carcinoma.
This new batch of CRLs comes after the FDA confirmed to various media outfits last week that it would suspend the release of the rejection letters after getting hit with a citizen petition in April. The freeze was first widely reported July 8. Including the rejection letters to Jiangsu and Elevar, however, a total of 14 CRLs were published on the FDA’s portal after the pause, according to a July 11 analysis by Citeline.
BioSpace has reached out to the agency to determine if it has decided to resume the release of CRLs and how the citizen petition might change its policy of making these documents publicly available.
The FDA first unveiled the CRL repository in July 2025 as part of its campaign for “radical transparency.” Another batch of rejection letters was released in September that year—alongside a promise that the agency would make these documents pubic as soon as they are issued to the sponsors.
“The reception from the investment community has been unanimously positive,” TD Cowen’s Ritu Baral told BioSpace in an April interview, referring to the public release of CRLs. “Frankly, I think it brings a level of accountability and professionalism to a sector that is far from mature.”
At the BIO International Convention last month, however, Eva Temkin, who had previously worked at the FDA’s Chief Counsel’s office and Office of New Drugs, pointed out the irony of the agency’s opaque process behind enacting a policy to improve transparency. “We’re going to force transparency, but we’re going to do it without transparent process,” she said.
In April, an unnamed pharma company filed a citizen petition against the policy, asking the FDA to “immediately cease publishing” the CRLs. The company, through its representative Covington & Burling, called the release of CRLs “unlawful,” noting that it “contravenes decades of agency practice with no adequate explanation.”
