Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance publication are a frequent side effect of changes in administration, after the January 2025 executive order (EO) announcing a “10-to-1” deregulatory policy, many have wondered what guidance development and publication might look like going forward. Drawing from multiple corners of FDA, recent actions from the agency may begin to paint a picture for us, showing a mix of traditional and novel approaches.
Generic Drug Product Specific Guidances (PSGs)—Delayed Business as Usual?
On May 20, 2025, FDA released a substantial batch (48 in number) of new and revised draft PSGs. These guidances, a cornerstone of generic drug development, provide detailed scientific recommendations to facilitate the development of generic drugs and the approval of abbreviated new drug applications (ANDAs), typically including testing and data recommendations used to establish that the generic drug is bioequivalent to its specific reference listed drug (RLD). PSGs are typically issued on a quarterly basis.
However, this release—originally expected in February 2025—was notably delayed, which raised questions about whether FDA would continue its usual cadence of PSG development or reduce output amidst evolving regulatory priorities and the EO. This release, though routine in its content, may be read as an affirmation of FDA’s long-standing commitment to facilitating drug and biologic competition and, as such, aligns with the US administration’s April 2025 executive order on lowering prescription drug prices through increased access to generics and biosimilars. If and when FDA publishes the next batch of PSGs will be worth keeping an eye on.
This most recent batch may have been developed before staffing cuts at the agency led to reductions in resources available for the development and publication of policy documents and it is unclear at this juncture how that may impact guidance development in this space moving forward. FDA may view the release of PSGs as occurring outside of the deregulatory policy because PSGs are governed by the agency’s user fee commitments, as described on the PSG webpage.
FDA’s Evolving Approach to COVID Vaccine Policy—New Ways of Disseminating Policy?
While the recent PSGs release underscores a continued commitment to generic drug development, FDA’s evolving regulatory posture is reflected in other public health areas—notably, its policy on COVID-19 vaccines. FDA recently adopted a more targeted, risk-based approach for COVID-19 booster approvals, prioritizing adults aged 65 and older and individuals with high-risk conditions. FDA will also require vaccine manufacturers to conduct clinical trials demonstrating the safety and efficacy of COVID-19 vaccines in healthy individuals (ages six months to 64 years) before approving them for this population.
While notable in its substance, the shift in policy is also notable for how and where it was announced by FDA. Previous iterations of FDA policy on COVID-19 vaccine development have been published on FDA’s website, like its other guidance documents. The accompanying Federal Register notice both cited FDA’s Good Guidance Practices regulations in connection with this publication and explained the relationship of the then-current recommendations from the Agency with previous iterations of policy. This recent announcement, however, has not resulted in updates published in this manner. Instead, the change was announced via publication of a commentary in the New England Journal of Medicine. Although this publication “represent[s] the policy position of the Food and Drug Administration,” to date, its relationship to existing guidance has not been further clarified. It remains to be seen whether nontraditional avenues for policy dissemination continue to be employed by FDA moving forward and whether or how these practices may relate to broader administration policies regarding deregulatory efforts.
Medical Device Policy—Diverging Paths for Draft and Final Guidance?
In contrast to the approach taken with respect to COVID-19 vaccine policy updates, FDA’s recent three guidances—two in May 2025 related to the Q-Submission program (a draft Electronic Submission Template and a finalized Requests for Feedback and Meetings) and a third in June 2025 (a draft on the Transfer of a Premarket Notification (510(k)) Clearance)— reflect a more traditional approach to guidance publication and may signal different paths forward for future draft and final guidance publication.
In terms of substance, the Q-submission guidances enhance predictability in the premarket process for medical device sponsors, helping reduce the administrative burden on the agency by promoting uniform submission formats and earlier alignment on regulatory expectations. For instance, the electronic Q-submission template is designed to standardize and simplify interactions with FDA, which can minimize back-and-forth exchanges and improve review timelines—ultimately reducing cost and delay. Second, by revising and consolidating existing guidance (as seen in the updated Q-submission program guidance), FDA is taking steps toward refining and modernizing its regulatory processes without expanding its footprint. Similar to the goal of the Q-submission guidances, the Transfer of a 510(k) Clearance draft guidance seeks to provide predictability and clarity by providing information on frequently asked questions related to the sale or transfer of ownership of a 510(k) clearance.
Notably, the two draft guidances were issued without implication of the 10-to-1 EO or consideration of cost. The Federal Register notices for both documents (here and here) note that FDA will consider the application of the 10-to-1 EO on any costs or cost savings “as [the Agency] develops final guidance on this topic.” This demonstrates that draft guidance may remain a vehicle for FDA to more freely communicate its current thinking. This is not insignificant. Although draft guidances are not for implementation, they provide integral insights into FDA’s current posture and expectations. As time passes, we may continue to see an increase in the issuance of draft guidance on various topics, but whether these guidances will be finalized in a timely manner, including to fulfill user fee-related commitments, remains to be seen.
In contrast, the final Q-submission guidance on Requests for Feedback and Meetings appears to have been moved across the goal line due to FDA’s interpretation that the approaches in the guidance are viewed as deregulatory. The Federal Register notice specifically notes that FDA has considered the relevant executive order “and finds this action to be deregulatory in nature,” thus presumably providing a path forward for publication that comports with the existing executive orders.
Key Takeaways and Looking Ahead
Taken together, these guidance documents and policies may foreshadow how FDA may continue publishing necessary guidances under the current deregulatory framework. Rather than abandoning guidance development altogether, FDA appears poised to focus on targeted, high-impact areas consistent with other goals of the administration, finding novel avenues for communicating agency policy, and finding other ways to keep stakeholders informed of evolving agency policy that potentially reduce—not expand—regulatory footprints.
With the deregulatory request for information (RFI) remaining open for comments until July 14, 2025 (Docket #AHRQ-2025-0001), stakeholders should expect clarification on FDA’s guidance publication policies in the future. The open RFI also presents an opportunity for industry to engage with FDA and provide input on these regulatory reforms.
Stakeholders across various FDA-regulated product categories should continue watching closely how FDA balances its mission—supporting innovation and access to medical products and promoting the public health—while navigating regulatory rollbacks and changes under the current administration.