Bill of Health

JANUARY 30, 2023

By Minsoo Kwon Telehealth services that specialize in the treatment of mental health concerns, such as Cerebral Inc., While increased accessibility of mental health care services through telehealth is a valuable goal, if our aim is the well-being of patients, safety must be paramount.

COVID-19 176

COVID-19 Public Health Doctors Nurses 176

Healthcare IT News - Telehealth

MARCH 18, 2022

Although the consumer perception and stigma around mental health was starting to change before COVID-19, the pandemic generated widespread acceptance and adoption of mental and behavioral healthcare services. Furthermore, patients and providers were encouraged to try novel technology solutions. Hospitals are faced with impossible decisions.

Medicaid 202

Medicaid Medicaid COVID-19 Telemedicine 202

Healthcare Law Blog

OCTOBER 25, 2023

Effective January 1, 2022, an individual in Oregon who acts as a pharmaceutical representative for more than 15 days during the calendar year must have, and renew annually, a license from the Department of Consumer and Business Services (“DCBS”). xii] SafeRx Amendment Act of 2008. xi] Washington D.C. 2017 Nevada Laws Ch.

Licensing 52

Licensing Compliance FDA Public Health 52

Health Law Advisor

JANUARY 30, 2023

Food and Drug Administration (“FDA”) to withdraw approval of Mifepristone, an FDA-approved drug used to end pregnancies in the first trimester. [1] The lawsuit has sparked concern by both industry and the FDA. Twenty years later, Congress codified the pathway in the FDA Safety and Innovation Act (“FDASIA”) [4].

FDA 59

FDA US Department of Health and Human Services Governance Doctors 59

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

OCTOBER 10, 2022

The drug at issue was an FDA-recognized breakthrough drug that treats a relatively rare, but invariably fatal, condition – transthyretin amyloid cardiomyopathy (“ATTR-CM”). 3 (2008), the court explained that “the word ‘includes,’ when used in a statute, ‘is usually a term of enlargement, and not of limitation.’” Pfizer, Inc. ,

Medicare 52

Medicare Medicare FDA Prescription Drug Pricing 52

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

Drug & Device Law

APRIL 25, 2022

Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. 2015) (“we will not consider evidence of a subsequent improvement to a drug label as evidence of prior failure to warn, even in cases such as this in which the FDA mandated the change in labeling”) (citing Rule 407).

FDA 52

FDA Governance 52

Drug & Device Law

JANUARY 30, 2023

440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. 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. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72