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11 Dec 2020, 5:11 am
However, in August 2020, HHS directed that, absent rule and commenting and at least during the COVID-19 public health emergency, the FDA would not require premarket review and approval of LDTs. [read post]
10 Dec 2020, 1:43 pm
Among other things, the ADR final rule: Establishes a new six-member “340B Administrative Dispute Resolution Board” comprised of officials drawn from within HHS, which will sit in three-member “Administrative Dispute Resolution Panels”; Provides for the initiation of claims by covered entities or manufacturers against each other seeking “monetary damages” and/or equitable relief (e.g., injunctions), which are forms of relief that may exceed the authority… [read post]
8 Dec 2020, 10:00 pm
The coronavirus (COVID-19) pandemic has made the development and use of drug and device products to diagnose, treat, or prevent COVID-19 essential. [read post]
8 Dec 2020, 10:00 pm
The coronavirus (COVID-19) pandemic has made the development and use of drug and device products to diagnose, treat, or prevent COVID-19 essential. [read post]
8 Dec 2020, 10:00 pm
The coronavirus (COVID-19) pandemic has made the development and use of drug and device products to diagnose, treat, or prevent COVID-19 essential. [read post]
8 Dec 2020, 10:00 pm
The coronavirus (COVID-19) pandemic has made the development and use of drug and device products to diagnose, treat, or prevent COVID-19 essential. [read post]
8 Dec 2020, 10:00 pm
The coronavirus (COVID-19) pandemic has made the development and use of drug and device products to diagnose, treat, or prevent COVID-19 essential. [read post]
8 Dec 2020, 10:00 pm
The coronavirus (COVID-19) pandemic has made the development and use of drug and device products to diagnose, treat, or prevent COVID-19 essential. [read post]
8 Dec 2020, 11:09 am
December 7, 2020 (LifeSiteNews) – In the latest indication of a possible Biden administration’s hard-left direction, former Vice President Joe Biden has tapped California’s extremely pro-abortion Democrat Attorney General Xavier Becerra to serve as his Secretary of Health and Human Services, should he take control of the White House. [read post]
8 Dec 2020, 7:03 am
A 12-term congressman and vocal supporter of the ACA, Becerra would become the first Latino to lead the federal agency if confirmed. [read post]
7 Dec 2020, 10:00 pm
With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act. [read post]
7 Dec 2020, 10:00 pm
With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act. [read post]
7 Dec 2020, 10:00 pm
With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act. [read post]
7 Dec 2020, 10:00 pm
With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act. [read post]
7 Dec 2020, 10:00 pm
With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act. [read post]
7 Dec 2020, 10:00 pm
With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act. [read post]
7 Dec 2020, 12:15 pm
There are also a few region-specific waiver programs such as that of ARC (Appalachian Regional Commission) and the DRA (Delta Regional Authority), and waiver applications can be filed with HHS (Health and Human Services), among other agencies. [read post]
7 Dec 2020, 10:29 am
Politico reports that HHS Secretary Azar on Sunday “defended the Trump administration’s vaccine plans and said distribution could begin in a matter of days pending approval by the FDA,” while Bloomberg reports he predicted, “all Americans who want to get a Covid-19 vaccine should be able to do so by the second quarter of next year. [read post]
7 Dec 2020, 10:14 am
Medicaid establishes coverage requirements for the states, but there is a provision in federal law that allows states to deviate from those requirements with the approval of HHS. [read post]
7 Dec 2020, 9:21 am
Xavier Becerra was tapped as HHS Secretary, which means he is out of the running for Attorney General. [read post]
