Law360: There were major developments in June 2025 for the future of one of the US Department of Justice's (DOJ’s) most potent and far-reaching tools—the Foreign Corrupt Practices Act (FCPA).

Law360: The Trump administration's pullback on Foreign Corrupt Practices Act (FCPA) enforcement is sowing confusion in the white collar bar, as companies consider whether to voluntarily disclose potential violations of the anti-bribery law while the chances of getting a favorable resolution seem good or keep quiet until the dust settles.

Law360: An abrupt pause in Foreign Corrupt Practices Act (FCPA) enforcement has created tension between clients eager to resolve investigations and their lawyers, who are having trouble reaching decision-makers at the US Department of Justice (DOJ) and are more inclined to await further guidance from the government.

Law360: The US Food and Drug Administration (FDA) Commissioner said on 11 April 2024 that the agency did not consider hemp-derived CBD safe enough to be sold lawfully as a dietary supplement, and urged Congress to create a new pathway to regulate the substance.

The US Food and Drug Administration (FDA) has announced a final rule which will ensure the safety and effectiveness of laboratory developed tests (LDTs). The rule amends the FDA's regulations to clarify that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) also when the manufacturer of the IVD is a laboratory. In addition, the FDA is finalising a policy which will provide greater oversight of IVDs offered as LDTs via a phaseout of its general enforcement discretion approach for LDTs over the course of four years, including targeted enforcement discretion policies for specific categories of IVDs manufactured by laboratories. The FDA will issue a policy for the new rule on the regulation of LDTs and a webinar on 14 May 2024.

The US Food and Drug Administration (FDA) has established the CDER Center for Real-World Evidence Innovation (CCRI) to streamline the use of real-world data and real-world evidence (RWE) in regulatory decision-making. The FDA has created this focal point within CDER to identify ways to utilise RWE in developing safe and effective medicines for unmet needs. CCRI will concentrate on scientific review, policy development, outreach, regulatory science initiatives, and knowledge management. The FDA encourages sponsors considering RWE use to engage with the agency early and contact their therapeutic review division for discussions with the RWE team.

The U.S. Food and Drug Administration (FDA) has released draft guidance on artificial intelligence (AI)-enabled device software functions, focusing on lifecycle management and marketing submission recommendations. The guidance advocates a total product lifecycle approach to ensure safety and effectiveness, covering design, development, implementation, and documentation aspects. It addresses transparency and bias considerations, complements recent guidance on predetermined change control plans, and encourages early engagement with the FDA. The draft is open for public comment until 7 April 2025, aiming to provide comprehensive recommendations for AI-enabled medical devices throughout their lifecycle.

The Food and Drug Administration has launched the Emerging Drug Safety Technology Program (EDSTP), a program focused on the used of artificial intelligence (AI) and other emerging technologies in pharmacovigilance (PV) and is part of the Center for Drug Evaluation and Research's (CDER) approach to enhance mutual learning of where and how specific innovations, such as AI, can best be used across the drug product lifecycle.

The US Food and Drug Administration (FDA) has published guidance and its recommendations for sponsors to study multiple versions of a cellular or gene therapy in an early phase clinical trial for a single disease. This guidance aims to assist sponsors conduct umbrella trials of similar products for the same disease in parallel with a view to shorten timelines and bring cell and gene therapies to market sooner. The FDA outlines that while 'multiple versions of a product can be studied together in a single clinical trial, each version of the product is distinct and is generally submitted to FDA in a separate investigational new drug application (IND)'. Early-stage umbrella trials 'are not intended to provide primary evidence of effectiveness to support a marketing application' and generally cannot demonstrate efficacy among the study arms of the trial, but can inform how to organise and structure the INDs, submit new information, and report adverse events, ultimately assisting with identifying the better versions of a therapy for a disease.

The FDA Trade Union has announced that it has submitted an application for judicial review against the UK government’s Safety of Rwanda (Asylum and Immigration) Act 2024 (SR(AI)A 2024). The FDA has expressed that it is concerned because SR(AI)A 2024 allows for ministers to have discretion over applying Rule 39 orders from the European Court of Human Rights and by ignoring such an order this would breach international law. The FDA alleges in their claim that if a minister chose to ignore a Rule 39 order, a potential conflict may arise for civil servants between instructions given by that minister and the legal obligations under the Civil Service Code. FDA General Secretary Dave Penman has stated that the 'challenge is not about the policy itself', but rather aims to 'defend our members and the integrity of the civil service'.

The FDA plans to establish a Rare Disease Innovation Hub to address the significant unmet needs for treatments for over 10,000 rare diseases affecting 30 million Americans. The Hub will leverage expertise across the agency and enhance collaboration to spur development of rare disease treatments. It will serve as a connection point with the rare disease community, enhance intercentre collaboration on scientific and policy issues, and advance regulatory science in areas like novel endpoints and trial designs. It will be co-led by the FDA’s Center for Drug Evaluation and Research (CDER) and the FDA’s Center for Biologics Evaluation and Research (CBER) directors and collaborate with other FDA centres to build on existing rare disease programs and facilitate engagement with external stakeholders through a new leadership position. While progress has been made, the Hub aims to improve outcomes for rare disease patients by addressing common challenges and facilitating safe and effective product development through enhanced cross-agency collaboration. The FDA anticipates holding a public meeting in Autumn 2024 to receive community feedback on shaping the Hub's priorities.

The Foreign, Commonwealth & Development Office (FDCO) has announced that the UK has imposed new sanctions on four Myanmar military-linked entities and infantry divisions involved in the repression of the civilian population and human rights violations. Under the Myanmar sanctions regime, the UK has sanctioned 25 individuals and 33 entities. The sanctions that have now been imposed target Myanmar military divisions that were responsible for human rights violations and entities that provided economic resources and support to Myanmar security forces, including two state-owned enterprises. The sanctioned groups will be subject to asset freezes and travel bans. The UK has issued a joint statement with eight other countries condemning continued violence and repression of people in Myanmar.