FDA plans rules to rein in drug ads, enable proactive release of CRLs, and more
The Trump administration has released its latest unified agenda, laying out the proposed and final rules its agencies plan to issue in 2026, including 22 final and 43 proposed rules by the US Food and Drug Administration (FDA).
Among the items in the agenda are FDA's plans to propose new regulations that would grant the agency the authority to proactively disclose complete response letters (CRLs), rules to require full risk disclosure statements for direct-to-consumer (DTC) prescription drug advertisements, and measures to reduce delays in clinical trials.
The unified agenda is traditionally issued twice per year; however, the Trump administration has sidestepped the release of a Fall 2025 agenda after having last issued a Spring 2025 agenda in September 2025. While the planned rules include an expected timeframe for publishing a notice of proposed rulemaking, agencies frequently exceed those timeframes, in some cases for multiple years. (RELATED: FDA’s latest regulatory agenda pulls LDT rule, spells out plans to issue a final rule on NDC, Regulatory Focus 5 September 2025)
Proactive disclosure of CRLs
FDA plans to issue a proposed rule in October 2026 that would “clarify and expand the discretion” of the FDA commissioner regarding the public release of CRLs and not approvable letters.
The rule follows a transparency push that kicked off in July 2025 to publish complete response letters in real time, including for drugs that have not yet gone on to be approved. Previously, the agency would only publish CRLs for drugs after they were approved.
“The benefits of the proposed rule would be increased transparency into FDA decision-making on CRLs, which may help future sponsors avoid submitting applications with the deficiencies explained in the CRLs,” FDA said. (RELATED: FDA publishes 200 complete response letters in transparency effort, Regulatory Focus 10 July 2025)
FDA announced that “this rule will eliminate the longstanding presumption that the mere existence of a marketing application constitutes confidential commercial information, thereby enabling proactive disclosure of CRLs for unapproved products while maintaining appropriate redactions for trade secrets and personal private information.”
The agency said it plans to redact prior to any public disclosure confidential commercial information (CCI), trade secret information (TSI), and personal private information (PPI)) under the Trade Secrets Act and section 301(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA said in the agenda that “there are compelling public interests favoring the disclosure of CRL information and a good cause finding for this rule. Sponsors can leverage this valuable information to avoid common missteps and to provide enhanced predictability leading to more meaningful cures and treatments.”
Some observers have questioned the agency’s legal basis for publishing CRLs for applications that have not yet been approved.
One attorney who spoke at the DIA Global Annual Meeting in Philadelphia last month argued that the publication of CRLs for unapproved drugs violates the agency’s own regulations and the Administrative Procedure Act; in addition, a recent citizen petition filed by law firm Covington & Burling also questions the FDA's authority to issue CRLs before applications have been approved and without providing the sponsors of those applications an opportunity to engage in the redaction process. (RELATED: Expert: FDA’s real time release of CRLs may violate law, hinder discussion with sponsors, Regulatory Focus 16 June 2026)
DTC advertising
FDA indicated it would propose a rule that would require broadcast advertisements for drugs to include a complete "brief summary" of all side effects and contraindications as specified in the approved labeling. This proposed rule is expected to be issued in December 2026.
This action is part of the agency's efforts that began in September 2025 to strengthen enforcement against what the agency said are misleading prescription drug advertisements. It aims to end a longstanding practice that enables drug companies to include a major risk statement in their ads while directing audiences to find more complete risk information elsewhere. As part of this initiative, the FDA has announced plans to begin rulemaking to eliminate what it referred to as the "adequate provision" loophole. (RELATED FDA cracks down on drug ads, promises to end adequate provision ‘loophole’, Regulatory Focus 10 September 2025)
The agency said that the adequate provision has been misused to conceal critical safety risks in both broadcast and digital advertisements, leading to inappropriate drug use and undermined public trust. A legal expert told Focus last year that this initiative overlooks the existing FDA regulations that govern fair and balanced advertising.
Clinical trial reform
FDA also plans issue a proposed rule for expedited Investigational New Drug (IND) reform to “modernize and streamline the Investigational New Drug (IND) application process for Phase 1 clinical trials by reducing unnecessary regulatory burden through targeted, risk-based flexibilities.”
This plan was announced against the backdrop of broader program launched by the Department of Health and Human Services (HHS) last month called “Operation Trailblazer” to expedite development of new drugs. (RELATED: HHS and FDA proposed clinical trial reforms to expedite drug development, Regulatory Focus 23 June 2026)
Under one part of the initiative, pharmaceutical companies would partner with qualified research institutions, such as academic medical centers or contract research organizations, to develop Phase 1 IND submissions for FIH clinical trials, using a rolling IND submission platform, with the goal of minimizing the need for clinical holds.
FDA said that “the action is needed to accelerate patient access to promising investigational therapies while maintaining appropriate human subject protections. By facilitating earlier clinical development of innovative drugs, this rule is expected to reduce delays that can adversely affect patient health outcomes and to address regulatory risks that are disproportionate to the low-risk nature of many early-phase studies.”
Other proposed rules
Among the dozens of upcoming proposed rules, FDA said it plans to amend the current good manufacturing practice (CGMP) regulations in 21 CFR parts 210 and 211 (drugs) and 600-800 (biologics) to clarify their application to advanced manufacturing technologies, including continuous manufacturing, distributed manufacturing, and point-of-care manufacturing.
FDA said “the proposed amendments would clarify how manufacturers may apply a science- and risk-based approach to CGMP compliance when using advanced manufacturing technologies, including flexible approaches to defining batches, modern control strategies based on real-time monitoring and material traceability, and lifecycle-based validation and process verification.”
FDA is also planning to propose a rule to modernize its regulations on postmarketing safety reporting and pharmacovigilance for human drug and biological products “by capturing important new safety-related information, improving the quality and utility of submitted reports, and supporting enhanced efficiency and alignment with internationally harmonized reporting guidelines.”
Additionally, FDA said it will propose new regulations covering the submission of initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This rule, if finalized, would give FDA the authority to require pediatric studies for certain drugs and biological products.
