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…
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/ Administrative Law, Health
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…
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/ Health, International Law & Trade, Science, Computers, & Technology
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…
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/ Administrative Law, Health, Science, Computers, & Technology
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…
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/ Administrative Law, Consumer Protection, Health, Science, Computers, & Technology
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…
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/ Health, Science, Computers, & Technology
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…
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/ Health, Intellectual Property, International Law & Trade
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…
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/ Communications & Media Law, Health
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;…
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/ Administrative Law, Health, Science, Computers, & Technology
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…
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/ Commercial Law & Contracts, Finance & Banking, Mergers & Acquisitions, Health, Science, Computers, & Technology
On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major barrier to the use of real-world evidence (RWE) in medical device regulatory submissions…
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/ Administrative Law, Health, Science, Computers, & Technology
The US Food and Drug Administration’s (FDA’s) Breakthrough Devices Program was established to facilitate earlier patient access to novel medical devices addressing serious health conditions, by offering prioritized review and…
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/ Administrative Law, Health, Insurance, Science, Computers, & Technology
At the end of 2025, as part of a bundle of measures to make the EU health sector more innovative, competitive and resilient, the European Commission proposed the EU Biotech Act (the Act) aimed at repositioning the EU as a global…
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/ Health, International Law & Trade, Science, Computers, & Technology
In a pre-Christmas gift, the European Commission has adopted a proposal to simplify Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR): Proposal for a…
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/ Administrative Law, Health, Science, Computers, & Technology
Two and a half years after the initial proposal, agreement has been reached by the EU institutions on the so-called EU Pharma Package. The Package represents a comprehensive overhaul of the European Union’s pharmaceutical…
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/ Health, Intellectual Property, International Law & Trade
On December 8, 2025, FDA announced a pilot for certain digital health devices in connection with the Center for Medicare and Medical Innovation’s (CMMI’s) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS)…
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/ Administrative Law, Health, Science, Computers, & Technology
