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Artificial Intelligence Pharmaceutical Industry Center for Drug Evaluation and Research (CDER)

Venable LLP

HHS Finalizes Staffing Cuts, New CDER Director, CDER Hiring Data, and New AI Councils at FDA

Venable LLP on

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions....more

Gardner Law

FDA Layoffs, RFK Jr. at HHS, and What This Means for FDA-Regulated Companies

Gardner Law on

In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more

Goodwin

Six Hot Trends in Life Sciences for 2025

Goodwin on

The life sciences industry is well positioned for growth in 2025, fueled by strong investor interest and technological advancements, especially in AI. Life sciences venture capital (VC) funding and IPOs have picked up in...more

Jones Day

Vital Signs: Digital Health Law Update | Fall-Winter 2024

Jones Day on

We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

BakerHostetler

Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products

BakerHostetler on

On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between...more

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