News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Regulatory Standards Regulatory Oversight

Dickinson Wright

Look Before You Leap – Early Determination of Product Classification and Regulatory Pathway for FDA-Regulated Products

Dickinson Wright on

Originally published in Healthcare Michigan, Volume 41,  No. 4 - The Food and Drug Administration (FDA) regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary...more

K&L Gates LLP

An Overview of the US Food and Drug Administration's Legislative Goals (Part I)

K&L Gates LLP on

In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more

Seyfarth Shaw LLP

Seyfarth on CBD – February 2020 Update

Seyfarth Shaw LLP on

CBD continues to flourish in the markets despite lack of federal regulations, and we’ve identified some significant events that indicate there’s no sign it’s stopping. ...more

Stinson LLP

Cosmetics Regulation: Where It Is and Where It May Be Going

Stinson LLP on

On March 5, the U.S. Food and Drug Administration (FDA) simultaneously published its independent testing results confirming the presence of asbestos in certain cosmetic products sold by Claire’s and by the girls'...more

Hogan Lovells

Parsing products: FDA regulatory policy for multi-function medical devices

Hogan Lovells on

On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical...more

Seyfarth Shaw LLP

A Celebrity Visit to D.C. Calls Attention to Cosmetics Regulations Reform

Seyfarth Shaw LLP on

Seyfarth Synopsis: What brings a celebrity to the Hill? A look at the current state of cosmetics regulations and potential effects of the Personal Care Products Safety Act that has gained famous support. ...more

Robinson+Cole Health Law Diagnosis

FDA’s New Draft Guidance on Bulk Drug Substances in Compounding

This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under...more

Bradley Arant Boult Cummings LLP

Third Circuit Grants Express Preemption in “Hybrid” Medical Device Case

On March 1, the U.S. Court of Appeals for the Third Circuit, in Shuker et al. v. Smith & Nephew PLC, affirmed a District Court’s ruling that claims against a medical device manufacturer are expressly preempted by federal law....more

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