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Food and Drug Administration (FDA) › Clinical Trials › New Regulations

Foley & Lardner LLP

Clinical Trials: FDA Issues Finalized Charging Guidance for Investigational Drug Use 

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In February 2024, the U.S. Food and Drug Administration (FDA) published its finalized guidance concerning its investigational drug charging regulations (found at 21 C.F.R. § 312.8). These regulations are applicable to...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Health Care Compliance Association (HCCA) on

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Jones Day

JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes

Jones Day on

Jones Day partner Maureen Bennett talks about how advancements in digital technology and their clinical trial applications have introduced additional regulatory regimes in the United States and the European Union, and...more

Polsinelli

FDA Deputy Commissioner Details Agency’s Priorities In Recent Speech

Polsinelli on

In This Issue: - Snapshot of the Agency: FDA-regulated products - Recent Public Health Milestones - Innovative Programs at FDA ..A. FDA has a number of programs intended to speed the availability of...more

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