HIT Consultant

MAY 12, 2022

Notable transactions in the consumer and member tech category include: Pear Therapeutics , software-based medicine provider, made its mark in 2017 as its tool became the first digital therapeutic approved by the FDA with claims to improve clinical outcomes.

COVID-19 98

COVID-19 FDA Licensing 98

SQA

AUGUST 8, 2023

The rules also cover other services that perform activities related to clinical analysis examinations, such as isolated (private) offices and pharmacies, which are considered health services since the publication of Law 13.021/2014. The rules of RDC 786/2023 correspond to a normative update, which replaces RDC 302/2005.

FDA 40

FDA Compliance COVID-19 World Health 40

Bill of Health

AUGUST 29, 2022

They are at the mercy of authority figures from multiple systems—the judiciary, government officials who oversee their day-to-day health, safety, and wellbeing, parents or legal guardians who may retain control over their bodily autonomy and decision making, and service providers who have access into the story of their lives.

COVID-19 Vaccine 130

COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

FDA 52

FDA Fraud Informed Consent 52

Drug & Device Law

AUGUST 8, 2022

A myriad of other industry, medical, and online organizations certify and rate an almost endless variety of goods and services. Ohio 2007) (“courts have repeatedly held that trade associations, themselves, have no duty to users of products in that trade”); Commerce & Industry Insurance Co. Such power rests solely with the FDA.”

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

MARCH 7, 2022

544 (2007), and Ashcroft v. These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., Greystar Management Services, L.P. , June 18, 2020); MCI Communications Services, Inc. The ruling in question was that the TwIqbal ( Bell Atlantic Corp. Twombly , 550 U.S.

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59

Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. In discussing Planned Parenthood of Greater Texas Surgical Health Services v.

FDA 127

FDA Licensing 127