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The VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to Fruition

USA - May 20 2022 Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full…

James A. Boiani

Chevron Deference: Is It Time for Change?

USA - February 15 2022 This term, the Supreme Court of the United States is set to rule in a Medicare reimbursement case that has sparked a fresh look at the historical…

Stuart M. Gerson, Robert E. Wanerman

Federal and State Cannabis Rules Are Moving in Different Directions

USA - June 3 2021 Federal and state cannabis regulation and enforcement appear to be moving in different directions. While the Food and Drug Administration (“FDA”) has…

Delia A. Deschaine, Nathaniel M. Glasser

Holding Pattern: Cannabis Industry Waits for FDA Regulatory Rulemaking

USA - September 3 2020 This Diagnosing Health Care Episode dives into the status of the Food and Drug Administration’s (“FDA’s”) plan for regulating cannabis and…

Delia A. Deschaine

FDA Issues Draft Guidance on Cannabis Clinical Research and Sends CBD Enforcement Discretion Guidance to OMB for Review

USA - July 28 2020 FDA took two important steps last week to clarify the regulatory landscape for cannabis products, including CBD products. First, FDA issued a draft…

Delia A. Deschaine, James A. Boiani