New Jersey Healthcare Blog

JULY 22, 2022

Below are the most recent health care related regulatory developments as published in the New Jersey Register in April-July 2022: April 2022. On April 4, 2022, at 54 N.J.R. On April 4, 2022, at 54 N.J.R. 290 (2022). On April 4, 2022, at 54 N.J.R. 292 (2022). On April 4, 2022, at 54 N.J.R.

COVID-19 Vaccine 40

COVID-19 Vaccine Licensing COVID-19 Public Health 40

Health Law RX

JUNE 27, 2023

Earlier, in the SuperValu decision (discussed in a recent Health Law Rx Blog ), the Court clarified that subjective intent is relevant in determining whether an objectively reasonable (but incorrect) interpretation of a rule or regulation could negate the FCA’s scienter element ( U.S. 3d 250, 252 (D.C. Bayer Healthcare Pharms., UCB, Inc. ,

Governance 52

Governance Fraud Compliance 52

SQA

AUGUST 8, 2023

In August 2022, ANVISA published Resolution RDC 741/2022 , which sets the framework to consider other medical device market regulators’ authorizations. The affected lots of Emerade were distributed in Canada between April 2022 and May 2023. Recalls All Lots of Emerade Epinephrine Auto-Injectors (0.3 mt and 0.5 mg and 0.5

FDA 40

FDA Compliance COVID-19 World Health 40

Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. 171, 212 (Fall 2022). 2003), review denied (Cal. Brown , 348 F.3d

Governance 52

Governance Payment Systems Hospitals Licensing 52