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New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

President Obama Signs Federal GMO Law, Preempts Vermont Law

On July 29, 2016, U.S. President Barack Obama signed into law the first U.S. federal law requiring food manufacturers and distributors to label products that contain genetically modified organisms (“GMO”).[1] The law...more

First-Ever Federal Labeling Requirements for Bioengineered Foods Signed Into Law

On July 29, President Obama signed into law a bill establishing first-ever federal requirements for the labeling of food containing genetically engineered ingredients. The bill, known as S.764, directs the U.S. Department of...more

Congress Passes GMO Labeling Bill – Preempting State Labeling Laws

In response to recent state efforts to regulate the labeling of food products containing genetically modified organisms (GMOs), the U.S. House of Representatives, on July 14, passed S. 764, a Senate-initiated bill...more

Five of the Top Drug & Device Developments in 2015

As 2015 winds down, we reflected on some of the year’s most significant legal developments for drug and device manufacturers. In our opinion, the bench got it right (for the most part) this year. Here is a brief recap and...more

Can A State Impose Civil Penalties On A Drug Or Device Company For Using A Federally-Approved Label?

Overview - States have increasingly brought actions under Medicaid fraud or consumer protection statutes seeking civil penalties and restitution from the makers of prescription drugs. Many top-selling drugs have been...more

Two More From The Supreme Court

Generic Manufacturers Win Preemption In Mensing The Court decided 5-4 in favor of generic preemption today in Pliva, Inc. v. Mensing, No. 09–993, slip op. (U.S. June 23, 2011). We’d like to talk about Mensing, but it’s a...more

Pro Te: Solutio - Vol. 3, No. 4 - October 2010

In this issue: FDA Warning And Untitled Letters - Using Historical Reference To Avoid Receiving Them In The Future; Healthcare Reform - Actions That Can Be Implemented Today To Prepare For Changes; Generic Preemption After...more

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