Manufacturers, Food & Drug Regulations, Medical Devices

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

Knobbe Martens on 3/18/2024

As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

340B Developments in 2024 – Litigation and Legislation

Quarles & Brady LLP on 3/14/2024

Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more

FDA on Board With Continuing Remote Inspections

Jones Day on 2/22/2024

The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more

Drug Supply Chain Security Act Compliance Extended But Trading Partners Should Still Prepare Now

Quarles & Brady LLP on 8/30/2023

On Friday, August 25th, the Food and Drug Administration (“FDA”) issued a guidance document extending the November 27, 2023 enforcement deadline for drug and device manufacturers, wholesale distributors, dispensers, and...more

Do you know when to report a medical device complaint?

Gardner Law on 9/14/2022

Whether you manufacture a Class I elastic bandage or a Class III deep-brain stimulation device, understanding when to report a medical device complaint is critical and is also required for all FDA regulated medical devices....more

Does CPSC or FDA Have Jurisdiction Over Your Consumer Product?

Mintz - Consumer Product Safety Viewpoints on 7/29/2015

As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more