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WilmerHale
Prost, J. The Court affirmed the district court's indefiniteness determination but vacated and remanded its nonobviousness determination as to the asserted patent.
Mintz
Madison said, "Looking at the historical context of why pregnant women are excluded from these studies is important," referencing a period when the use of thalidomide by pregnant people to treat nausea...
Goodwin Procter LLP
As we previously reported, the U.S. Department of Justice ("DOJ") filed a lawsuit under the Anti-Kickback Statute against Regeneron Pharmaceuticals in the District of Massachusetts...
Exponent
On March 15, the Food and Drug Administration issued new draft guidance that impacts premarket submissions for all medical devices that produce temperature changes in patient tissues...
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
The Trademark Trial and Appeal Board affirmed the Trademark Office's refusal of CBH International LLC's application to register the composite word-and-design mark...
Exponent
On Nov. 17, the Food and Drug Administration released the final guidance for assessing the credibility of computational modeling and simulation (CM&S) in medical device submissions.
Exponent
Updates on conducting a toxicological risk assessment of medical device extractable and leachable constituents for FDA submissions
Exponent
Four questions for developing inclusive digital solutions by identifying women-specific requirements and endpoints
Global Advertising Lawyers Alliance (GALA)
Dole markets a variety of fruit products – such as Fruit Bowls in Gel, Fruit Bowl Parfaits, and Canned Juices – with various health-related claims.
Farrell Fritz, P.C.
We live in an age of scientific miracles. We have an unprecedented ability to identify the causes of disease, and we have access to treatments, and even cures, we could not imagine only a few decades ago.
Ankura Consulting Group LLC
Since California first passed legislation legalizing medical marijuana in 1996, the legal landscape involving medicinal and recreational marijuana has grown significantly.
Dickinson Wright PLLC
One of the most popular incentives for service industry employees is the "Shift Drink" – a drink on the house to unwind after a work day.
K&L Gates
Food manufacturers should pay close attention to the recent developments surrounding chlormequat chloride (chlormequat), a chemical that plaintiffs claim has been detected...
Foley Hoag LLP
Nearly two years after the Court overturned Roe v. Wade in June 2022, additional challenges are being brought that may limit access to abortion in the U.S. Mifepristone...
Exponent
Major revision to human factors engineering guidance for the design of medical devices slated for release later this year.
Manatt, Phelps & Phillips LLP
On March 18, the Biden Administration announced that it is doubling down on its commitment—previously announced during President Biden's State of the Union address...
Winston & Strawn LLP
The U.S. District Court for the Eastern District of Virginia is the latest court to weigh in on the continuing debate surrounding the scope of the Federal Anti-Kickback Statute (AKS) as it applies to patient assistance programs (PAPs).
Mintz
The PBM regulatory landscape continues to evolve rapidly at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised...
Holland & Knight
The Centers for Medicare & Medicaid Services (CMS) on April 10, 2024, released a proposed rule for the fiscal year (FY) 2025 Inpatient Prospective Payment System (IPPS)...
Ogletree, Deakins, Nash, Smoak & Stewart
As the Minnesota Legislature enters the latter half of its 2023–2024 legislative session, the pressure is on to meet critical deadlines before adjournment on May 20, 2024.
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