Exeed Regulatory Compliance

MARCH 5, 2020

FDA Guidance on EUA, Jan 2017 *Notes: Section 564 as in the Food, Drug and Cosmetic (FD&C Act); PAHPRA refers to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2015 One area of current concern is the lack of diagnostic testing capability in the US to rapidly detect and confirm new cases.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

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. 325, 338 (2005). [21] In this post, I argue that young people should have the opportunity to consent to vaccines. Barnette , 319 U.S. 624, 63 S.Ct.

COVID-19 Vaccine 130

COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Kaiser Health News

FEBRUARY 9, 2023

Biden’s calls for bipartisanship to extend health programs like pandemic-era subsidies for Affordable Care Act health plans are expected to clash with conservative demands to slash federal government spending. Rovner: Sarah, is the FDA worried about this case? They said they don’t think that would help.

US Department of Health and Human Services 52

US Department of Health and Human Services Medicare Medicare FDA 52

Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. at 349 (“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance”). Medtronic, Inc. ,

FDA 59

FDA Governance Nurses Hospitals 59

Drug & Device Law

APRIL 25, 2022

Back in 2010, we examined one restrictive judicial gloss on Rule 407 – a “policy” based exception that the rule somehow doesn’t apply to government-mandated measures. Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. continue to be subject to Rule 407-based exclusion.

FDA 52

FDA Governance 52

Drug & Device Law

JANUARY 25, 2024

Put simply, among the morass of Medicare are provisions governing Medicare Advantage programs, which companies can elect to provide and eligible people can elect to receive. 308 (2005), which comes up not infrequently in drug and device product liability cases. Darue Eng’g & Mfg. ,

Medicare 52

Medicare Medicare FDA Regulatory Compliance 52

Drug & Device Law

JANUARY 30, 2023

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. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72