Bill of Health
FEBRUARY 16, 2022
Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions. Banning Menthol Cigarettes. Reviewing E-cigarettes.
Bill of Health
MARCH 28, 2022
Food & Drug Administration (FDA) encouraged several states to adopt policies that prioritized race or ethnicity in the allocation of monoclonal antibody treatments and oral antivirals for the treatment of SARS-CoV-2. By James Lytle. Recent guidance from the U.S. New York’s Policy.
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Fierce Healthcare
OCTOBER 20, 2021
FDA contracts Aetion’s real-world evidence platform to assess COVID-19 treatments. Wed, 10/20/2021 - 16:59.
Bill of Health
JANUARY 7, 2022
Over the summer of 2021, concern grew that the vaccines were not providing the near-perfect protection against symptomatic disease and transmission that had first emboldened the administration to jettison other public health measures. In response to the perceived overreach, two high-level FDA vaccine regulatory officials resigned in protest.
Health Populi
FEBRUARY 28, 2021
With a third vaccine approved by the FDA for licking COVID-19, brought to market by Johnson & Johnson, the U.S. That’s such welcome news and a positive outlook for a healthier 2021. The chart here comes from IQVIA’s latest study into COVID-19’s impact on U.S.
Dot Compliance
NOVEMBER 2, 2022
Prior to the COVID-19 pandemic, during fiscal year (FY) 2019 (October 1, 2018, through September 30, 2019), the FDA conducted 7,266 GMP inspections of registered drug, device and biologics establishments. The post <strong>The FDA Ramps Up GMP Inspections</strong> appeared first on Dot Compliance.
Healthcare Law Blog
JANUARY 12, 2022
On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Guidance Overview. How long can I continue to do so? .
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