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New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.”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

The silver lining in the DEA’s refusal to reclassify cannabis

As far back as 2011, elected officials have sent letters to the U.S. Drug Enforcement Administration urging it to reclassify cannabis by removing it from the list of Schedule I controlled substances. After promising a...more

The DEA Is Getting Past Just Saying No: Scientific Research Into Medical Uses of Marijuana Is a Bridge Toward a Policy Shift

The U.S. Drug Enforcement Agency (DEA)’s recent decision declining to reschedule cannabis is a step bridging the national discussion — a step toward a possible agreement on medical cannabis through scientific research. The...more

Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard – and More

Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison...more

DEA Rejects Petitions Seeking to Reschedule Marijuana

The long-awaited decision maintains the illegal status of marijuana under federal law. On August 12, the US Drug Enforcement Agency (DEA), despite much speculation to the contrary, published in the Federal Register its...more

FCC Thwarted in Efforts to Preempt State Broadband Laws

The U.S. Court of Appeals for the Sixth Circuit has struck a major blow to the FCC’s efforts to remove barriers to broadband service and promote competition in broadband markets. In State of Tennessee v. FCC, the court...more

Sixth Circuit Rejects FCC’s Effort To Preempt State Regulation Of Municipal Broadband Providers

The FCC’s February 2015 meeting yielded two significant and controversial orders premised on the agency’s authority under Section 706 of the Communications Act: its much-publicized Open Internet Order, and its less-publicized...more

Regulators Nationwide Weigh in on CPUC Litigation

In May, we posted a blog on litigation filed by telecom providers and trade associations to prevent the California Public Utilities Commission (CPUC) from requiring Plaintiffs to turn over competitively sensitive data to a...more

California Court Clears The Way For Express Preemption

Not everyone sees eye to eye on federal preemption, including judges. Take for example the conflicting opinions from the California Court of Appeal applying the express preemption provision of the Medicare Prescription Drug,...more

Obama signs GMO label bill into law

On Friday, July 29, US President Obama signed into law S. 764, which overturns Vermont's GMO label law and establishes a national standard for GMO (genetically modified organism) labeling. The US House of Representatives...more

New Federal Drone Regulations Leave Unanswered Questions

The Federal Aviation Administration Extension, Safety, and Security Act of 2016 (“FAA Reauthorization”) was signed into law July 15. The FAA Reauthorization contained at least five sections directed specifically at unmanned...more

New GMO Legislation Signed into Law

With Congress’s freshly enacted GMO labeling bill, the devil is in the implementing details. On July 29, US President Barack Obama signed legislation that establishes a national disclosure requirement for identifying...more

Update: Unraveling the Toxic Substances Control Act Reform Bill

In June, the U.S. Senate and House of Representatives passed the long-pending Toxic Substances Control Act (TSCA) reform legislation, which will bolster the government’s power to regulate a wide variety of chemicals. The bill...more

Drone Regulations: Federal vs. State

In early 2016 a group of well-meaning Wisconsin legislators introduced legislation designed to allow local municipalities to regulate the use of drones in their given communities and to create a penalty enhancer for crimes...more

The “Most Contentious Issue” — Federal Preemption in the Amended Toxic Substances Control Act

This client alert is the third in a series that discusses the significant changes instituted by the passage of a new federal Toxic Substances Control Act. The first alert addressed broadly the law’s myriad of changes. The...more

A One-Two Punch Case With An Off-Label Twist

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense. For more important stuff, we find qualifiers like “vague” and...more

Congress Passes GE Labeling Bill, President Obama Expected to Sign Bill Into Law

On July 14, 2016, after more than a year of on-and-off debate and failed attempts at legislative compromise, Congress finally passed a bill to require the creation of a federal labeling standard for bioengineered food within...more

Breaking News: Physical Presence Requirement Bill Introduced in Congress

On July 14, 2016, Congressman Jim Sensenbrenner (R-WI) introduced the No Regulation Without Representation Act of 2016 (H.R. 5893) in the US House of Representatives (House). The bill would codify the physical presence...more

Congress Passes National GMO Disclosure Law

On Thursday the U.S. House of Representatives passed S. 764, a Senate-initiated bill establishing a national uniform standard for labeling of bioengineered foods, sometimes referred to as genetically modified foods or GMOs....more

Congress Passes GMO Labeling Bill, President Obama To Sign into Law

On July 14th, Congress passed a GMO labeling bill by a vote of 306-117 that would preempt Vermont’s mandatory labeling act that went into effect on July 1st. The White House said President Obama will sign the bill into...more

Senate Passes GMO Bill Creating A National Bioengineered Food Disclosure Standard With Federal Preemption And Exclusion...

On July 7, 2016, the Senate passed a bill, An Act to Reauthorize and Amend the National Sea Grant College Program Act, and for Other Purposes (S. 764), through agreement to the House's amendment to S. 764, with further...more

One Step Closer to a National GMO Labeling Law

The Vermont GMO Labeling Law is currently in effect, but it may soon be preempted by federal legislation making its way through Congress. On July 7, by a vote of 63-30, the US Senate passed a measure (Senate Bill)...more

Another Prescription Drug Warnings Preemption Decision

Not that our readers are dying for a glimpse behind the curtain into the making of the sausage (and mixed metaphors) of the blog, but we do try to first figure out what decisions may be blogworthy before we start writing up...more

The Difference Between Manufacturing and Design Defects

Some plaintiffs seem to think that if they allege any problems about anything in the manufacturing process of a prescription medical product, then it falls under the rubric of “manufacturing defect.” They’re wrong, of course....more

TSCA Reform Presents Solutions and Questions for Industry

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the first amendments to the Toxic Substances Control Act (TSCA) since its passage in 1976. The amendments...more

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