article thumbnail

Tobacco Issues Awaiting Robert Califf at the FDA

Bill of Health

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 274
article thumbnail

SQA Regulatory Surveillance Summary 4 | Monthly Update 2021

SQA

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.

FDA 52
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Can Children Consent to the COVID Vaccine? The Case of Foster Care and Juvenile Justice

Bill of Health

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].

article thumbnail

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

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
article thumbnail

Double Shot Thursday:  “The More Things Change” And “Of Puppets And Standing”

Drug & Device Law

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.