Verisys

JULY 13, 2023

How to Tackle Pharma’s 3 Biggest Compliance Risks Head-On with Verisys How often have you started at a new organization and heard these phrases? “ Some companies make decisions based on compliance standards and optics, while others may be more lax. Clinical trial compliance can offer unique challenges for pharmaceutical companies.

Compliance 52

Compliance Due Diligence Pharmaceutical Industry Fraud 52

C&M Health Law

JANUARY 25, 2023

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. 2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. In 2023, these include United States ex rel. Polansky v. 3d 239 (Cal.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Levine , 555 U.S. 555 (2009), and rated only a “ cf.

FDA 72

FDA Fraud Governance Medicare 72