Regulatory Oversight, Manufacturers, Healthcare

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on 8/22/2025

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

FDA Moves Forward on Fluoropolymers

Akin Gump Strauss Hauer & Feld LLP on 8/7/2025

On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical...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

Stay ADvised: 2025, Issue 6

Davis Wright Tremaine LLP on 3/27/2025

Reckitt Benckiser Tastes Sweet Success as Mucinex Honey False Ad Dismissed - Plaintiffs alleging that Reckitt Benckiser falsely advertised certain Mucinex products as containing honey failed to sufficiently allege that the...more

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

Hogan Lovells on 12/13/2018

Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more

France tightens grip on industry payments to HCPs (again)

Hogan Lovells on 1/24/2017

On 19 January 2017, major modifications were adopted in France to the regulations on interactions between the industry and healthcare professionals (and other stakeholders). These new regulations, a.k.a. "anti-benefits...more