Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Hogan Lovells
On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), ...
McDermott Will & Emery
In U.S. ex rel. J. William Bookwalter, III, M.D. et al. v. UPMC et al., the US Court of Appeals for the Third Circuit endorsed two controversial interpretations of the Stark Law's...
Squire Patton Boggs LLP
The Sixth Circuit activity continues to escalate as the MDL bellwether trial date approaches. In just the last week, since the Court of Appeals' rare order
Foley Hoag LLP
On September 18, 2019, the Department of Justice announced a $21.36 million settlement to resolve a False Claims Act ("FCA")
Duane Morris LLP
The goal for CMS is to keep those providers and suppliers that have committed fraud out of the federal healthcare programs.
Wilson Elser Moskowitz Edelman & Dicker LLP
A product liability lawsuit has been filed in Washington state court against several manufacturers of THC vape cartridges.
Shook, Hardy & Bacon L.L.P.
Shook Partners Hildy Sastre and Jennise Stubbs, along with Of Counsel Sonali Gunawardhana, have co-authored the USA section of Chambers and Partners'
BakerHostetler
Acting FDA Commissioner Discusses Food Safety Modernization Act (FSMA) Progress – Acting Commissioner Sharpless announced the Food ...
Seyfarth Shaw LLP
Welcome back to The Week in Weed, your Friday look at what's happening in the world of legalized marijuana.
Foley Hoag LLP
The U.S. Department of Justice (DOJ) continues to actively target the healthcare industry for False Claims Act (FCA) and other alleged violations, and it took significant steps ...
Arnold & Porter
The trial was bifurcated into two evidentiary phases: falsity and knowledge.
Venable LLP
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced last week that it entered into a Resolution Agreement with a Florida medical center ("Medical Center")
Akin Gump Strauss Hauer & Feld LLP
On September 19, Speaker Pelosi released a drug pricing plan that includes proposals for Medicare direct price negotiation and international reference pricing.
Sheppard Mullin Richter & Hampton
On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement...
Shook, Hardy & Bacon L.L.P.
Shook Partner Chris Kaufman and Associate Torrey Peterson have co-authored an article for DRI's For the Defense on "Exposing Meritless Claims in Drug and Medical Device Product Liability MDLs."
Wilson Elser Moskowitz Edelman & Dicker LLP
Massachusetts has taken a drastic and abrupt step by banning the sale of all vaping products, nicotine and THC, within its state borders for the next four months.
McLane Middleton, Professional Association
Question: My spouse requires long-term care in a nursing home and Medicaid benefits to finance such care. Will I be able to continue living in my home?
Mintz
As promised, the Department of Health and Human Services (HHS) filed a brief in the United States Court of Appeals for the District of Columbia Circuit challenging the district court's
Seyfarth Shaw LLP
Welcome back to The Week in Weed, your Friday look at what's happening in the world of legalized marijuana.
Cadwalader, Wickersham & Taft LLP
A Luxembourg-based global agribusiness and a Minnesota-based global agribusiness settled CFTC charges separately (see here and here)...
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Jones Day
Data privacy- and security-related class actions appear to be on the rise, and effectively defending them requires the right mix of substantive and procedural knowledge.
Oblon, McClelland, Maier & Neustadt, L.L.P
Design patents are very different from utility patents in that design patents only protect the ornamental features of an invention. In contrast to utility patents, the design is defined
Jones Day
On the heels of the European Union's General Data Protection law, which went into effect in May 2018
Butler Snow LLP
Many state legislatures across the country have enacted statutory measures to limit the amount of compensatory and/or punitive damages recoverable ...
Sheppard Mullin Richter & Hampton
On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement...
Dentons
The House passes historic legislation to provide banking services to the cannabis industry.
Duane Morris LLP
The Medicare for all program could eliminate the private health insurance system as we know it.
Dentons
Plans to vote on cannabis banking legislation announced in both chambers of Congress, with predictions that House will pass the SAFE Act by the end of October
Shook, Hardy & Bacon L.L.P.
Plaintiffs' attorneys are spending billions of dollars saturating the airwaves with advertisements that target prescription drugs and medical devices for lawsuits.
McDermott Will & Emery
First introduced in 2013, the SAFE Banking Act passed the House 321-103 yesterday. This bill provides safe harbor to banks and financial institutions...
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