Bill of Health

FEBRUARY 16, 2022

Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions. Banning Menthol Cigarettes.

FDA 279

FDA COVID-19 Vaccine Public Health COVID-19 279

Bill of Health

AUGUST 29, 2022

Despite pediatric COVID-19 vaccine availability, many youth remain unvaccinated , and are thus at higher risk of life-altering outcomes as a result of contracting COVID-19. [1]. Specific to the COVID-19 vaccine, children under age 18 in most jurisdictions will require parental consent. [8].

COVID-19 Vaccine 130

COVID-19 Vaccine COVID-19 Informed Consent Governance 130

SQA

JUNE 10, 2021

Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021. That’s why the government is implementing a multi-faceted procurement strategy to provide a COVID-19 vaccine to every Canadian who wants one by September.

COVID-19 52

COVID-19 FDA COVID-19 Vaccine Compliance 52

Drug & Device Law

FEBRUARY 8, 2024

In Hinton , the plaintiff’s sling was implanted in August 2019, after pretty much all the relevant FDA actions on pelvic mesh devices. In addition, the decision affirmed the dismissal of a case against FDA over orders related to pediatric authorizations for two COVID vaccines. 23-51067, 2024 WL 244938 (5th Cir.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 FDA Public Health 52

Drug & Device Law

DECEMBER 29, 2023

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. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

FDA 105

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