Compliancy Group

AUGUST 14, 2023

Regulatory compliance in the healthcare industry plays a crucial role in patient safety, maintaining quality standards, and preventing fraud and abuse. There are key strategies that should be followed to achieve regulatory compliance. Something is wrong with your submission.

Regulatory Compliance 52

Regulatory Compliance Compliance Compliance Officers Fraud 52

Verisys

NOVEMBER 30, 2022

Maintaining compliance and safeguarding against fraud and abuse in today’s changing healthcare landscape can be challenging. Excluded from one means excluded from all, and the fines for non-compliance will likely be in the hundreds of thousands. OIG, SAM DEA, GSA, FDA. 5,600+ Total Sources. 2,500+ State Sources.

Regulatory Compliance 52

Regulatory Compliance Medicare Medicare Medicaid 52

Health Care Law Brief

JUNE 2, 2022

For example, the Department of Justice has aggressively pursued health care fraud claims against individuals and entities involved in non-compliant telehealth models. How will the marketing comply with the FDA rules regarding the marketing of prescription drugs and/or professional practice rules applicable to licensees?

Public Health 52

Public Health Compliance COVID-19 Licensing 52

Drug & Device Law

MAY 24, 2022

In both New Jersey and Florida, there is a strong presumption against punitive damages in drug and device cases where there’s been regulatory compliance. In response to the summary judgment motions, plaintiff abandoned 11 of those claims including various strict liability, fraud/misrepresentation, and warranty claims.

FDA 52

FDA Regulatory Compliance Compliance Fraud 52

Drug & Device Law

DECEMBER 29, 2023

2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. Monsanto Co. ,

FDA 105

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

Drug & Device Law

JUNE 5, 2023

April 21, 2023), became the latest decision to follow what used to be (before the Pelvic Mesh litigation used the law in this area as a settlement tool) the overwhelming majority rule, that FDA decisions to allow products to be marketed – including §510(k) clearance – were routinely admissible. The Kelley court agreed with the defendant.

FDA 59

FDA Regulatory Compliance Compliance Fraud 59