SQA

FEBRUARY 15, 2023

” The reason: The existing document of the EU GMP Guideline dates back to 2011 and no longer corresponds to the state of the art in various areas or does not consider increasingly important new technologies for the GMP field, according to the EMA. ” The requirements for providers (e.g.,

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA 98

FDA Licensing Hospitals Medicaid 98

C&M Health Law

JANUARY 25, 2023

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Hall Render

MARCH 16, 2022

2471 ) that funds the federal government for the remainder of FY 2022. The measure includes funding for health care-related agencies, such as HHS, CMS, HRSA and the FDA, as well as several health care policy riders and provisions that address issues like 340B and telehealth waivers. million increase. billion increase.

COVID-19 40

COVID-19 Medicare Medicare FDA 40

Drug & Device Law

DECEMBER 12, 2022

223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead. The Supreme Court did its part in Bruesewitz v. Wyeth LLC , 562 U.S. Now comes DeCostanzo v. at 226 (footnote and quotation marks omitted). 300aa-11(a)(2)(a).

FDA 115

FDA Public Health Fraud Hospitals 115

Drug & Device Law

DECEMBER 29, 2023

Executive Health Resources, Inc. , 2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. At bottom, plaintiffs were improperly seeking to have courts second-guess the FDA’s methods and conclusions.

FDA 105

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

Drug & Device Law

MAY 10, 2022

Nor can they include the logo of a federal or state government agency, so as not to suggest affiliation with any such agency. Finally, they cannot use the word “recall” except “when referring to a product that has been recalled by a government agency or through an agreement between a manufacturer and government agency.”

Governance 52

Governance FDA Doctors Public Health 52