SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. These products are widely used by Canadians.

FDA 40

FDA Compliance Licensing World Health 40

SQA

OCTOBER 18, 2023

At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. In a 2015 survey, the overall prevalence of mineral supplement or vitamin use among Canadian men and women was 38% and 53%, respectively. These products are widely used by Canadians.

FDA 40

FDA Compliance Licensing World Health 40

Bill of Health

OCTOBER 31, 2024

Food and Drug Administration (FDA) is expected to propose new rulemaking on front-of-package labeling in 2024. For instance, in 2015, San Francisco passed a law requiring outdoor advertisements for sugar-sweetened beverages to include a health warning covering 20% of the ad space. Since 2009, the U.S. While the U.S.

Public Health 100

Public Health FDA Governance Licensing 100

Hall Render

DECEMBER 22, 2023

health care spending hits $4.5 911 dispatchers couldn’t understand them OKLAHOMA Children’s hospital in Oklahoma second in country with new therapy technology OU Health receives federal grant to support telemedicine for rural stroke patients OREGON Legacy Health sells medical office building for $60.5M

Nursing Homes 40

Nursing Homes Nurses COVID-19 Hospitals 40

Hall Render

DECEMBER 29, 2023

Penn Medicine buys Montgomeryville site for $7.5M of Health Won’t Release Details R.I. physicians group partners with Calif. health tech company Lifespan considering $300M bond issue for construction projects R.I.

Nursing Homes 40

Nursing Homes US Department of Health and Human Services COVID-19 Nurses 40

Hall Render

APRIL 21, 2023

Nevada, currently the wild west of birthing, is considering licensing midwifery NEW HAMPSHIRE Dartmouth Health opens new 5-story patient pavilion Report: Anthem has yet to process nearly $300 million in N.H. no longer calls for masks at all health care facilities to fight COVID-19, Gov.

US Department of Health and Human Services 40

US Department of Health and Human Services COVID-19 Nursing Homes Nurses 40

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

Drug & Device Law

NOVEMBER 9, 2023

In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here ), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. FDA , 119 F. Caronia , 703 F.3d 3d 149 (2d Cir. 3d 196 (S.D.N.Y.

FDA 64

FDA Health Insurance Nurses Medicare 64

Drug & Device Law

JULY 26, 2023

2015 WL 5567578, at *6-7 (W.D.N.C. 22, 2015) (admitting §510(k) compliance in pelvic mesh case under North Carolina law). So plaintiffs will not be able to hide the truth of FDA regulation from the jury on retrial, while misleading the jury, nor try the same trick in any other pelvic mesh case in New Jersey going forward.

Compliance 52

Compliance FDA Licensing Governance 52

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

FDA 59

FDA Licensing Hospitals Governance 59

Drug & Device Law

FEBRUARY 2, 2023

Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. 2015 WL 11120857, at *2 (N.D. 23, 2015) (same); Lewis v. manufacturer, . . & Rem.

FDA 59

FDA Licensing Fraud 59

Drug & Device Law

OCTOBER 27, 2022

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 2015); Otis-Wisher v.

FDA 59

FDA Licensing Compliance 59

Drug & Device Law

AUGUST 8, 2022

For qualified IMGs, it issues a certification, which IMGs can then use to apply to residency and other graduate medical education programs and to apply for state medical licenses. 2015 WL 6393869 (S.D. 21, 2015): Mississippi does not recognize any cause of action against a voluntary non-profit trade association like TMA. . . . [T]he

Doctors 52

Doctors Fraud Licensing Compliance 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. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir. Herzog , 788 F.3d

FDA 127

FDA Licensing 127

Drug & Device Law

MARCH 16, 2022

As you must know by now, the pelvic mesh MDL court ruled that the FDA 510(k) regulatory clearance of pelvic mesh devices was irrelevant because such clearance was not probative of safety. But the plaintiff did not file her lawsuit until March of 2015. Arizona March 1, 2022) – focuses on the regulatory status of the device.

FDA 69

FDA Governance Licensing 69

Drug & Device Law

MARCH 7, 2022

These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., It does not give him license to evade the less rigid ? It does not, however, give a plaintiff “license to evade the less rigid ? 2015 WL 3466517 (D. 2015); Tapia v. 6, 2015); Rhoton v.

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59