FDA Governance Informed Consent Public Health 
Bill of Health
JULY 14, 2023
The federal government’s commitment to assuring that participants in human subject research provide fully informed consent dates back to the U.S In 2017, Congress acted again to update the Common Rule and strengthen the provisions related to consent. While the U.S. These warnings echo those of the U.S.
SQA
FEBRUARY 15, 2023
Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.
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Bill of Health
AUGUST 29, 2022
Some children may be unvaccinated by no choice of their own, but instead because of decisions made by parents, guardians, or state or local government officials. In this post, I argue that young people should have the opportunity to consent to vaccines.
Hall Render
FEBRUARY 10, 2023
over Claims Practices Where things stand in Central California 1 month after a community hospital’s closure California hospital names Kelly Linden CEO Upcoming California health bills to watch, including a conversation with Rep. million to UMass Memorial Health Care for COVID-19 costs Four Mass. What to know.
Kaiser Health News
NOVEMBER 27, 2023
“We’re not going to be like California and have massive numbers of people on government programs without work requirements,” DeSantis said at a presidential primary debate in Southern California earlier this year. California bans short-term health plans. California Newsom became the first U.S.
Drug & Device Law
DECEMBER 29, 2023
Executive Health Resources, Inc. , 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. At bottom, plaintiffs were improperly seeking to have courts second-guess the FDA’s methods and conclusions.
Drug & Device Law
FEBRUARY 26, 2024
As much as we like preemption, no basis for preemption exists based with respect to the informed consent requirement of the statute’s provision governing emergency use authorized (“EUA”) products, such as (at the time) COVID-19 vaccines. Second, the FDCA (21 U.S.C. CHDI , 2024 WL 637353, at *5. quoting Jacobson , 197 U.S.
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