Regulatory Oversight, Healthcare, Clinical Trials

2025 Horizons Life Sciences and Health Care

Hogan Lovells on 8/25/2025

In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more

The Importance of a Clinical Trial Strategy

Gardner Law on 6/17/2025

Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

FDA in the “Computer Age” — AI Adoption Accelerates as Staffing Shrinks

Arnall Golden Gregory LLP on 6/5/2025

Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more

FDA Unleashes AI to Review Product Applications

Loeb & Loeb LLP on 5/27/2025

The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

Troutman Pepper Locke on 2/13/2025

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more

FDA Publishes Informed Consent Final Guidance for Drug and Medical Device Clinical Investigations

Nelson Mullins Riley & Scarborough LLP on 8/16/2023

The U.S. Food and Drug Administration (FDA or the Agency) has issued the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final Guidance). The...more

Minimizing the Fallout from Increasing FDA Clinical Holds

Nelson Mullins Riley & Scarborough LLP on 2/10/2023

With medical and scientific advances progressing at an exponential pace, FDA appears to be taking a more aggressive stance in imposing clinical holds on studies where adverse events are reported. Over the last several years,...more

FDA Issues Guidance on Drug and Biologic Submissions with Real-World Data and Real-World Evidence

Wilson Sonsini Goodrich & Rosati on 10/5/2022

Last month, the U.S. Food and Drug Administration (FDA) issued a final guidance on drug and biologic submissions to the agency that include real-world data (RWD) and real-world evidence (RWE). The procedural guidance aims to...more

FDA Releases Draft Guidance for Sponsors on How to Comply with Study Data Standards When Submitting RWD-Sourced Study Data

Faegre Drinker Biddle & Reath LLP on 11/4/2021

The U.S. Food and Drug Administration (FDA) issued a draft guidance titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data on October 21, 2021. The guidance provides the Agency’s thoughts...more

Device Modernization Series: In Vitro Clinical Tests

Mintz - Health Care Viewpoints on 3/8/2019

In our first two Device Modernization series posts, we discussed FDA’s 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts to retool oversight of laboratory...more

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

Ballard Spahr LLP on 12/16/2016

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

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