As Prescribed

The European Union’s new pharmaceutical legislation, the most significant reform of the EU medicines framework in over two decades, will have important implications for M&A, licensing, and other life sciences transactions. Notably, the reforms will reshape the regulatory rewards and incentives that often underpin pharmaceutical asset valuations by revising regulatory data protection, market protection, and orphan drug exclusivity, while also imposing additional obligations relating to supply and market access.

Since 1984, FDA has had authority to recognize three years of regulatory exclusivity for certain qualifying new drug applications that conduct new clinical investigations essential for its approval. Despite no shortage of controversy, nuance, challenges, and litigation in the intervening decades on its application of these provisions, FDA’s public-facing interpretation of these provisions was limited to slim regulation, citizen petition responses, and court filings. After promising its publication for some time, FDA has issued the draft guidance New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.

There have been a number of recent regulatory developments affecting medical devices and in vitro diagnostic devices in the EU, building on the European Commission’s proposal to simplify the medical devices regime published at the end of 2025, and in the UK. These developments include procedural requirements for notified bodies’ conformity assessment activities under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), political agreement on amendments to the EU Artificial Intelligence Act, and significant reforms to the UK medical devices regime.

FDA announced on March 11, 2026 the launch of the Adverse Event Monitoring System (AEMS), a modernized database designed to centralize and streamline the analysis and publication of adverse event reports for all FDA-regulated products. This new platform, with enhanced analytics and real-time data capabilities, marks a significant shift in how adverse event data is shared by FDA and accessed and used by industry and the public.

A recently issued Food and Drug Administration (FDA) Warning Letter citing a drug manufacturer for improper use of artificial intelligence (AI) suggests FDA’s scrutiny of AI is expanding. Although not the first FDA Warning Letter related to AI, prior Warning Letters focused on issues surrounding the regulatory status of the AI systems themselves, namely whether a given AI system was a medical device subject to FDA oversight.

FDA recently announced the issuance of the first voucher awarded under its restored Rare Pediatric Disease (RPD) Priority Review Voucher Program for a drug that was approved after the program’s previous sunset. The Consolidated Appropriations Act, signed into law on February 3, 2026, reintroduced voucher availability for RPD-designated drugs and created a safety net for designations made when vouchers were not immediately available.

As readers will be aware, at the end of 2025, the EU institutions agreed the text of the EU Pharma Package: the wholesale change to the pharmaceutical regime in the EU that has been debated for many years. The changes introduce wide ranging amendments that impact rewards and exclusivities, supply chain set up, and procedures for generics and biosimilars.

The UK Prescription Medicines Code of Practice Authority (PMCPA) has published revised social media guidance in a new dedicated section of its website, reflecting recent case precedent and the realities of an evolving digital landscape.

The FDA released updates to two guidance documents on January 6: General Wellness: Policy for Low Risk Devices (General Wellness) and Clinical Decision Support Software (CDS). FDA did not issue a traditional press release; instead, FDA Commissioner Makary took to social media to announce the updates in a video, in which he touted them as “promot[ing] more innovation with AI and medical devices” and that FDA has “a clear lane for medical grade products,” but needs “to adapt with the times and be proactive with guidance.” Consistent with the Commissioner’s messaging, the updates to the General Wellness guidance expand the types of products that qualify for enforcement discretion (i.e., do not need to comply with FDA’s device requirements). The updates to the CDS guidance, however, do not appear to significantly modify FDA’s interpretation of the CDS exemption. Nonetheless, these updated guidance documents signal FDA leadership’s willingness to ease regulatory burdens for digital health and wearables.

The Morgan Lewis cross-functional and cross-jurisdiction life sciences and healthcare teams were represented in San Francisco for the 44th Annual J.P. Morgan Healthcare Conference from January 12–15, 2026. The conference reinforced a familiar but evolving message for the life sciences and healthcare industries: capital remains constrained, exits are uncertain, and success increasingly depends on scale, optionality, strategic, and regulatory clarity. While the outlook for a potential reopening of public markets remains positive, structural shifts in funding, dealmaking, and investor behavior appear more enduring. This blog post discusses the principal themes that emerged from panels and private discussions throughout the week in the areas of life sciences dealmaking and the evolving regulatory landscape for medical products.