Health Law RX

JULY 28, 2022

This is a big jump compared to the 2007 legislative session when the legislation first allowing pharmacists themselves to administer only the flu vaccine was enacted, and only after a hard-fought legislative battle when most other states already allowed pharmacists to administer vaccines.

FDA 52

FDA Governance 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. 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].

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COVID-19 Vaccine COVID-19 Informed Consent Governance 130

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. 544, 559 (2007). [T]he 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”).

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FDA Governance Nurses Hospitals 59

Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. T]he growing market for mifepristone. . .

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FDA Medical Personnel Telemedicine Licensing 111

Drug & Device Law

NOVEMBER 10, 2023

These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions. FDA, “ Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications ” (Aug. Valsartan , 2023 WL 1818922, at *24.

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FDA Governance Fraud 59

Drug & Device Law

AUGUST 8, 2022

Furthermore, trade associations often serve to assist the government in areas that it does not regulate. Ohio 2007) (“courts have repeatedly held that trade associations, themselves, have no duty to users of products in that trade”); Commerce & Industry Insurance Co. Such power rests solely with the FDA.” Donnatacci , 531 A.2d

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

MARCH 31, 2022

The Court accurately perceived the issue as “not.simply a question of creating a new liability in the nature of a tort,” but rather one of “fiscal policy” and what branch of government properly sets such policy. Thus, the Standard Oil court rejected the government’s “tort law analogy” as a basis for “establishing. . . 2d 481, 489 (Md.

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Governance FDA Doctors Hospitals 52