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Rich May
The U.S. Drug Enforcement Administration approved an earlier opinion of the Department of Health and Human Services...
Bass, Berry & Sims
On May 21, the U.S. Court of Appeals for the D.C. Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract...
Axinn Veltrop & Harkrider
As part of the Food and Drug Law Institute's Annual Conference last week, Axinn Partner and FDA Practice Group Chair Chad Landmon participated in a panel titled...
Manatt, Phelps & Phillips LLP
The United States occupies a leadership position in clinical advancements, in terms of pharmaceuticals, medical devices, innovative care processes and interventional techniques.
Foley Hoag LLP
In the latest legal development in the ongoing 340B contract pharmacy litigation, the United States Court of Appeals for the District of Columbia Circuit...
Greenberg Glusker Fields Claman & Machtinger
The federal government has started to reclassify cannabis. When, and if, that reclassification is finalized, licensed cannabis businesses should see dramatically higher after-tax...
Michael Best & Friedrich
I've posted a lot about alternative protein sources. Everywhere I look in the food and beverage literature, I see another article touting the virtues of plant-based meats...
Manatt, Phelps & Phillips LLP
In Amgen Inc. v. Sanofi,1 the Supreme Court unanimously held that "[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter...
Axinn Veltrop & Harkrider
Last week, the Food and Drug Law Institute held its Annual Conference while also celebrating its 75th anniversary. There, members of FDA and industry players gathered to discuss the latest legal, policy, and regulatory...
Holland & Knight
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.
Greenberg Traurig, LLP
On May 16, 2024, the U.S. Department of Justice announced that the Attorney General has submitted a notice of proposed rulemaking initiating a formal rulemaking process...
Steptoe LLP
The Second Circuit, for the first time, has addressed the scope of the Supreme Court's decision in FTC v. Actavis regarding the use of allegedly anticompetitive reverse payments by a brand drug manufacturer to settle patent infringement litigation ...
Jackson Lewis
The Department of Justice (DOJ) published a Notice of Proposed Rulemaking to reschedule marijuana from Schedule I to Schedule III of the federal Controlled Substances Act (CSA)...
Foley & Lardner
On May 6, 2024, the U.S. Food and Drug Administration issued its final rule significantly modifying FDA's approach to oversight of laboratory developed tests.
Marks & Clerk
Welcome to Marks & Clerk's new series of articles regarding the nature and role of data in the patent system. This current article is intended to serve as an introduction to the series...
Holland & Knight
The U.S. Drug Enforcement Administration (DEA) on May 16, 2024, issued a proposed rule to move marijuana from its current classification as a Schedule I drug to a Schedule III drug...
Goodwin Procter LLP
On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs)...
Duane Morris LLP
On April 29, 2024, the U.S. Food and Drug Administration announced a final rule that amends existing regulations to make explicit that in vitro diagnostic products and tests, including laboratory developed tests, are devices regulated under the Federal Food, Drug and Cosmetic Act.
Exponent
New rule creates premarket review, reporting, quality system, and other requirements for laboratory developed tests...
Carter Ledyard & Milburn
Alex Malyshev and Sarah Ganley of Carter Ledyard & Milburn LLP analyze the legal and policy considerations of the Drug Enforcement Administration's move to reschedule Cannabis...
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