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Jones Day
On November 6, 2023, the Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") released its "General Compliance Program Guidance" ("GCPG").
Proskauer Rose LLP
As we approach December, the impending arrival of Santa Claus is no doubt dominating discussions in many households.
McGuireWoods LLP
A large damage award serves as a significant reminder to file an appearance in a False Claims Act (FCA) case.
Cooley LLP
The US Food and Drug Administration (FDA) is resolute in its quest to phase out its enforcement-discretion approach for laboratory-developed tests (LDTs).
Foley & Lardner
In the world of healthy food and beverages, a crucial first step towards bringing a new product to the crowded U.S. market is identifying and understanding...
Holland & Knight
U.S. Congress passed a "laddered" Continuing Resolution (CR) on Nov. 16, 2023, temporarily averting a government shutdown. The CR extended funding through Jan. 19, 2024...
Goodwin Procter LLP
Regeneron Pharmaceuticals, Inc. ("Regeneron") filed a Complaint on November 22 against Samsung Bioepis Co., Ltd. ("Bioepis") in the U.S. District Court for the Northern District of West Virginia...
Riker Danzig LLP
A federal court recently denied the U.S. Chamber of Commerce (the "Chamber") and their state and local chapters' request for a preliminary injunction to block Medicare from negotiating...
Hyman, Phelps, & McNamara, P.C.
Shortly before the Thanksgiving holiday, FDA announced with no fanfare that it would be holding a Molecular and Clinical Genetics Panel meeting this Wednesday November 29.
Foley & Lardner
OpenAI's GPT-4 correctly diagnosed 52.7% of complex challenge cases, compared to 36% of medical journal readers...
Oblon, McClelland, Maier & Neustadt, L.L.P
Recently Mylan in Mylan, Inc. v. Comm'r of Internal Revenue, 76 F4th 230 (3rd Cir. 2023), beat the tax man.
Goodwin Procter LLP
On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG.
McGuireWoods LLP
With the election season completed and the posture of each state's political chatter turning toward the 2024 session, now is a good time to take stock of where certain...
Foley & Lardner
On November 22, 2023, while many were preparing for the Thanksgiving holiday, the Office of Inspector General (OIG) posted a consumer alert (Alert) warning the public...
Foley & Lardner
This year's Going Digital Health's Behavioral Health Tech Conference (GDBH) was well-attended and rife with insightful panel presentations and discussions featuring key players from across...
IR Global
Messner Reeves LLP knows that the risk of litigation is always a concern for healthcare organizations, as companies strive to nimbly adapt to changes in state,...
Jones Day
The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers...
Wolf, Greenfield & Sacks, P.C.
In 1984, Congress passed and the President signed into law the Drug Price Competition and Patent Term Restoration Act, better known as the Hatch-Waxman Act.
On November 2, 2023, the American Hospital Association (AHA) – alongside the Texas Hospital Association, Texas Health Resources, and United Regional Health Care System...
Hyman, Phelps, & McNamara, P.C.
For any of our readers seeking recommendations on which drinks pair well with turkey this Thanksgiving, certain fruit-flavored beverages may be off the table.
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