FDA Publishes a Wide Range of Guidances in the Final Days of the Biden Administration

On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway. Under the Consolidated Appropriations Act, 2023, Congress gave the FDA the authority to require that a confirmatory trial be underway prior to the granting of accelerated approval or within a specific time period after the date of accelerated approval. This latest guidance comes on the heels of the accelerated approval guidance issued by the agency just last month (see prior analysis here), in which the agency stated its intent to address the 2023 authority in a separate guidance.

On January 6 and 7, 2025, the FDA announced, by our count, 31 draft or final guidances, on a wide range of topics. Historically, an incoming administration will impose a temporary freeze on the issuance of guidances and rules, and might ultimately have different policy priorities and goals than the previous administration. Thus, the release of these numerous new guidances reflects topics that the FDA likely views as particularly important to address.

On December 30, 2024, FDA unveiled an Idea Lab as part of its Home as a Health Care Hub initiative to reimagine how new and existing medical devices can be incorporated in a home environment.

On December 12, 2024, FDA’s Center for Drug Evaluation and Research (CDER) announced a new CDER Center for Real-World Evidence Innovation (CCRI). The CCRI is intended to serve as the focal point to promote more efficient and consistent communications across CDER offices regarding real-world data (RWD) and real-world evidence (RWE).

On December 5, 2024, FDA unveiled the draft guidance for industry regarding accelerated approval for drugs and biologics. This guidance provides additional information regarding the development of drugs and biologics to treat serious conditions for which there is an unmet need, and for which the sponsor is seeking accelerated approval. In particular, the guidance details the conditions for confirmatory study or studies that sponsors are required to conduct under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Consolidated Appropriations Act, 2023. This guidance also elaborates on the process for the expedited withdrawal of an accelerated approval. In announcing the availability of the draft guidance, the agency has requested comments be submitted by February 4, 2025.

Today FDA issued final guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI) enabled device software functions. FDA recognizes that development of AI-enabled devices is an iterative process, and PCCPs are intended to allow developers to plan for modifications, while continuing to provide a reasonable assurance of safety and effectiveness. FDA provides that a PCCP should include planned modifications, a methodology to develop, validate and implement those modifications, and an assessment of an impact of those modifications. FDA initially introduced the concept of PCCPs in a 2019 white paper, and the Food and Drug Omnibus Reform Act of 2022 created provisions regarding PCCPs. For example, a supplemental application for a device that received Pre-Market Approval (PMA) or a new 510(k) is not required for a change to a device that would otherwise require a PMA supplement or a new 510(k) if the change is consistent with a PCCP approved or cleared by FDA. This final guidance is specific to AI-enabled devices, although PCCPs may be submitted for devices other than AI-enabled devices, and FDA has issued draft guidance that applies more broadly to all devices.

In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical companies and medical device manufacturers can adopt to mitigate risks related to supply chain disruptions, cybersecurity threats and increased FDA enforcement of quality control and compliance.

On November 19, 2024, FDA issued a request for information (RFI) on per-and polyfluoroalkyl substances (PFAS) in seafood. Specifically, the agency is seeking scientific data and information from the seafood industry and other stakeholders and experts (e.g., academia, state and other federal agencies), on PFAS concentrations in seafood, the surrounding environment and processing water. The agency is also looking for mitigation strategies for reducing exposure to PFAS in seafood.