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
As Prescribed
As Prescribed, published by Morgan Lewis, focuses on regulatory and legal developments in the pharmaceutical and medical device sectors. The blog covers topics such as updates to European Union pharmaceutical legislation, FDA policies on digital health and biosimilars, and regulatory frameworks for rare disease therapies in the UK. It addresses changes in compliance requirements, approval processes, and enforcement discretion by regulatory agencies. The content also includes discussions on databases for medical devices and evolving standards for clinical trials and marketing authorizations, reflecting ongoing shifts in healthcare law and policy.
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Latest from As Prescribed
FDA Publishes Draft Guidance on Three-Year New Clinical Investigation Exclusivity
By Morgan Lewis
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…
Recent EU and UK Medical Devices Developments: EU MDR/IVDR, EU AI Act, UK Medical Devices Regime
By Morgan Lewis
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…
Adverse Events Centralized: What the Launch of FDA’s New Adverse Event Monitoring System Means for Companies
By Morgan Lewis
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…
FDA’s Warning Letter Suggests Growing Scrutiny of AI Overreliance
By Morgan Lewis
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…
FDA Grants First Voucher Under Restored Pediatric Disease Program
By Morgan Lewis
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…
The Impact of the EU Pharma Package on the UK
By Morgan Lewis
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…
UK PMCPA Refreshes Social Media Guidance: What In-House Teams Should Know
By Morgan Lewis
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.
New Year, New Guidance: FDA Revisits Wellness and CDS Boundaries
By Morgan Lewis
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…
Key Takeaways from the 2026 J.P. Morgan Healthcare Conference
By Morgan Lewis
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…