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Food and Drug Administration (FDA) › Cost Recovery

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

Morgan Lewis

FDA Issues Guidance on Expanded Access

Morgan Lewis on

The Agency improves the process for access to investigational drugs and biologics for patients who lack other options. On June 2, the US Food and Drug Administration (FDA or the Agency) announced that it finalized three...more

Mintz

FCC Modifies Cost Recovery Rules for Medical Device Tests and Proposes Greater Access to MedRadio Bands for Testing

Mintz on

On July 6, 2015, the Federal Communications Commission (“FCC”) adopted a Memorandum Opinion and Order modifying its rules covering Experimental Radio Service (“ERS”) licenses, which permit research and testing of radio...more

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