Navigating the Changing Regulatory Landscape in 2025

In just 10 months, the pharmaceutical regulatory landscape of the United States has changed radically. The restructuring of the FDA, its workforce turnover, and changing expectations regarding pharmaceutical innovation and compliance have created a climate of regulatory uncertainty. Thus, pharmaceutical leaders must now implement changes to create submissions that address this challenging environment. This article summarizes how the U.S. pharmaceutical oversight evolved in 2025, and what companies can do to adapt to a regulatory landscape in a constant state of flux.

A New Regulatory Landscape

The 2025 FDA changes have not only revamped regulatory requirements but also the way companies interact with the agency while trying to fulfill them. With the cut of approximately 3,500 positions, applicants should be prepared for longer review cycles, slower responses to informal interactions (via email, for example), and a diminished agency capacity to provide detailed feedback. Thus, being proactive is more critical than ever in order to have more chances of submission success.

In addition to reducing its staff, in early 2025, the FDA received executive mandates to cut down its required resources and regulatory workload. This was reflected in actions such as the “10-for-1” policy, which pushed federal agencies to eliminate 10 existing regulations for every new regulation introduced. This has slowed the release of new guidelines and encouraged sponsors to rely on older regulatory frameworks.

In contrast, regulators in foreign markets have also adjusted their requirements regarding pharmacovigilance, manufacturing practices, and clinical transparency. So while the U.S. is in a process of de-regulation, globally there is a push towards stricter standards that aim to harmonize regulatory requirements.

Managing FDA Submissions in 2025

There is a big difference between being open to change and being prepared for changes. In times of ever-evolving regulations, pharmaceutical leaders should focus on strengthening their capacity to manage updates that may affect their submissions, laboratory processes, and communications management. This can be achieved by implementing actions such as:

Establishing a proactive approach to regulatory readiness

Regulatory gaps discovered internally cost less than those revealed during inspections. In May 2025, the FDA announced that it would increase unannounced inspections of foreign facilities. Therefore, companies should reinforce internal regulatory compliance processes, manufacturing record management, data systems structures, and the inspection readiness of both U.S. and foreign sites.

Structuring how FDA communications are managed

Companies should adapt to work with an FDA that has a slower response and a smaller workforce. Thus, all communications should be optimized and managed systematically, no matter if it is a meeting request, an email, a call, or an electronic submission. Information should not be siloed between departments and team members to ensure continuity. This systematic approach should also be reflected in the structuring of submissions and support documentation to aid reviewers in providing more accurate feedback.

Being precedent-driven, change-ready

The release of new guidance documents may stall due to the FDA’s push towards de-regulation. Therefore, it might be better to create submissions that rely on historical agency decisions and established guidelines than to wait for the regulatory framework to be updated. It is also advisable to develop potential scenarios that outline the actions the submission team should take if delayed guidance is suddenly approved. The scenarios can then be used to build a modular submission development plan that allows for pivoting or can be re-used in a submission to a foreign agency. 

Prioritize Regulatory Awareness in Your Team

Team members should be aware of how dynamic the U.S. regulatory landscape has become. This requires transparency and the willingness to admit that some things are unknown. Beyond sending regulatory updates via email, leaders can help their team to prioritize regulatory awareness by creating a policy update dashboard, conducting post-review and post-inspections debriefings, and forecasting how policy changes made today can affect submissions planned in the upcoming months.

In conclusion, 2025 has become a year in which the regulatory landscape has been fundamentally reset. Beyond complying with new agency expectations, leaders of pharmaceutical companies must prepare to work in a dynamic regulatory environment and be more proactive. By strengthening regulatory know-how, improving inspection readiness and establishing clear lines of communication with regulators, companies can achieve and maintain compliance in times of regulatory uncertainty.