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Food and Drug Administration (FDA) › Pharmaceutical Industry › State Law Claims

Polsinelli

FDA Preemption of State Law for False Labeling Survives Appeal to Supreme Court

Polsinelli on

Manufacturers of dietary supplements, food, beverages, and even medical devices can breathe a little easier following the Supreme Court’s denial of certiorari this week in a case seeking to overturn a First Circuit decision...more

Nutter McClennen & Fish LLP

Product Liability 2018 Year in Review

Nutter McClennen & Fish LLP on

Massachusetts state and federal courts issued a number of important product liability decisions in 2018. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more

Mintz - Health Care Viewpoints

Biosimilar Market Developments Continue Apace in 2018

Mintz - Health Care Viewpoints on

It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products....more

Goodwin

Amgen v. Sandoz: Sandoz Requests Remand to District Court

Goodwin on

As we have previously reported, on June 12, 2017, the Supreme Court issued a unanimous opinion in Amgen v. Sandoz holding that notice of commercial marketing may be given prior to FDA approval. The Court also held that no...more

Foley & Lardner LLP

How Will The Supreme Court Choreograph The Biosimilar Patent Dance?

Foley & Lardner LLP on

On April 26, 2017, the Supreme Court heard oral arguments in Amgen v. Sandoz, where the parties have asked the Court to interpret two of the biosimilar patent dance provisions of the Biologics Price Competition and Innovation...more

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