The U.S. Food and Drug Administration posted a new batch of complete response letters to its online portal in July, just days after confirming a temporary suspension of public disclosure for these documents.
The latest set includes a letter dated July 9 that rejected Jiangsu Hengrui and Elevar Therapeutics’ application for a combination regimen using the PD-1 inhibitor camrelizumab and the VEGF blocker rivoceranib for hepatocellular carcinoma. Despite announcing the pause, the FDA published a total of 14 complete response letters following the suspension, according to a July 11 analysis by Citeline.
The agency had previously confirmed to various media outlets last week that it would halt releasing rejection letters after receiving a citizen petition in April. The freeze was first widely reported on July 8. BioSpace has reached out to the FDA to clarify whether it has resumed releasing these documents or if there will be changes to its transparency policy as a result of the petition.
The FDA launched its repository for complete response letters in July 2025 as part of an effort described as “radical transparency.” Another group of rejection letters was released in September that year, with assurances from the agency that such documents would be made public as soon as they were issued to sponsors.
TD Cowen’s Ritu Baral said in an April interview with BioSpace regarding public release of CRLs, “The reception from the investment community has been unanimously positive. Frankly, I think it brings a level of accountability and professionalism to a sector that is far from mature.”
At last month’s BIO International Convention, Eva Temkin, who previously worked at both FDA’s Chief Counsel’s office and Office of New Drugs, commented on how transparency was being implemented: “We’re going to force transparency, but we’re going to do it without transparent process,” she said.
In April, an unnamed pharmaceutical company filed a citizen petition against this policy through Covington & Burling. The petition called publication of CRLs “unlawful” and stated it “contravenes decades of agency practice with no adequate explanation.”
