FDA Unveils Transparency Roadmap — Plans More Disclosures

FDA has unveiled a new Transparency Roadmap that calls for expanded public disclosure of complete response letters, clinical study reports, inspection records and other regulatory information as part of a broader fiscal year 2027 transparency initiative.

The roadmap builds on FDA’s 2025 initiative to publicly release complete response letters (CRL). FDA said it intends to expand that effort while protecting confidential commercial and proprietary information, according to a post by FDA acting chief of staff and deputy commissioner for strategic initiatives Lowell Zeta.

The CRL postings, which were launched under former FDA commissioner Marty Makary as part of a broader “radical transparency” effort, are intended to provide drug developers, investors and the public with greater insight into FDA decisions. The transparency initiative quickly drew criticism from industry attorneys and regulatory experts, who questioned whether FDA had sufficient legal authority to release the CRLs before products were approved and whether sponsors should have an opportunity to review and redact confidential information before publication.

Under the proposed roadmap, one potentially significant change for drug and biologics companies is FDA’s plan to pursue rulemaking that would publicly disclose the submission of major marketing applications, including NDAs, BLAs and ANDAs. FDA also said it is encouraging sponsors to disclose the existence of investigational new drug applications when they are filed.

Under the initiative, FDA plans to increase post-approval disclosure of scientific data, including publication of appropriately redacted clinical study reports for approved applications, possible alignment with European Medicines Agency data-transparency practices, pilot projects involving expanded clinical datasets and greater disclosure of postmarketing data, according to Zeta’s post.

The roadmap also appears to mark FDA’s first use of the Trump administration’s new “super intelligence” terminology for artificial intelligence. FDA cited “super intelligence (SI)-assisted drug design” among technologies driving medical innovation and later referred to “SI-powered predictive toxicology” as a new approach methodology. President Trump issued a 9/29 executive order directing federal agencies to replace the terms “artificial intelligence” and “AI” with “super intelligence” and “SI” in official communications and other non-statutory documents.

The initiative also calls for greater transparency surrounding new approach methodologies, real-world evidence, decentralized trials and novel biomarkers. FDA pointed to its September launch of a public NAMs database containing 25 examples of how alternative methods have been incorporated into approved drug applications.

Another significant move involves inspections. FDA said it will build on existing inspection databases by proactively publishing redacted Form 483 inspection observations and additional establishment inspection reports when appropriate. The agency said greater disclosure should help companies better understand regulatory expectations and allow foreign regulators and the public to see more of the information underlying FDA compliance decisions.

Additionally, FDA plans to finalize regulations establishing standardized, one-page “Patient Medication Information” for outpatient prescription drugs and continue stepped-up oversight of direct-to-consumer (DTC) prescription drug advertising. A year ago, FDA launched a crackdown on misleading DTC advertisements. “This work remains a high priority and continues on two parallel fronts. For industry, the agency is seeking to create a level playing field by preventing bad actors from undermining compliant firms in the marketplace,” Zeta says. “The agency is also exploring new rules and guidances to provide clarity to industry on how advertising may be evaluated across modern forms of media.”

The agency characterized the roadmap as both a record of transparency initiatives completed during FY 2026 and an agenda for FY 2027, while emphasizing that increased disclosure will continue to be balanced against protections for trade secrets, confidential commercial information and sensitive health information.