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4 Feb 2021, 9:05 pm
Food and Drug Administration apply greater scrutiny to products that could enable genetic self-experimentation. [read post]
4 Feb 2021, 9:05 pm
Food facilities worldwide that do business in the United States must register with the Food and Drug Administration at the start of each odd numbered year. [read post]
4 Feb 2021, 8:30 pm
President Biden has promised to lead a highly ethical administration, which he has pitched as a contrast to his predecessor, and adopted strict rules form those serving in his administration, although they do not necessarily apply to family members. [read post]
4 Feb 2021, 7:06 pm
The Centers for Disease Control and Prevention (CDC), US Food and Drug Administration (FDA), Public Health Agency of Canada, and state partners investigated a multistate and multination outbreak of Salmonella Enteritidis in the summer of 2020 associated with Prima/Wawona peaches. [read post]
4 Feb 2021, 7:03 pm
Food and Drug Administration (FDA) investigated a multistate outbreak of Cyclospora infections linked to bagged salad mix purchased at ALDI, Giant Eagle, Hy-Vee, Jewel-Osco, ShopRite, and Walmart stores in 14 states, and produced at Fresh Express’s Streamwood, Illinois production facility. [read post]
4 Feb 2021, 4:03 pm
In December 2020, less than a year after severe acute respiratory syndrome coronavirus 2 was identified as the cause of the coronavirus pandemic, an extraordinary collaboration between scientists, the pharmaceutical industry, and government led to 2 highly efficacious, safe vaccines being approved by the US Food and Drug Administration to prevent coronavirus disease 2019 (COVID-19) infection.1,2 Had the US been in its expected role as a global leader in medicine and… [read post]
4 Feb 2021, 9:15 am
Daewoong recently received Food and Drug Administration (FDA) approval to market an injection in the United States that competes with Botox, owned by Allergan-Medytox. [read post]
4 Feb 2021, 9:15 am
Daewoong recently received Food and Drug Administration (FDA) approval to market an injection in the United States that competes with Botox, owned by Allergan-Medytox. [read post]
4 Feb 2021, 8:31 am
Last February, just before the coronavirus shutdowns put everything on pause, the Food and Drug Administration (FDA) issued a Drug Safety Communication for the weight-loss drug Belviq. [read post]
3 Feb 2021, 9:05 pm
Court of Appeals, the center is specifically challenging the Food and Drug Administration’s 2019 approval of soy leghemoglobin. [read post]
3 Feb 2021, 7:38 pm
This statistical association does not imply any kind of causal relationship between the administration of the drug and the occurrence of the adverse event. [read post]
3 Feb 2021, 1:52 pm
In its original outbreak notification on Jan. 13 the Food and Drug Administration’s weekly CORE investigation table listed 48 patients. [read post]
3 Feb 2021, 9:35 am
Food and Drug Administration, USDA’s Food Safety and Inspection Service (FSIS), and several state health departments. [read post]
3 Feb 2021, 5:01 am
As I noted in an earlier Lawfare post (co-authored with Chas Kissick), the Cyberspace Solarium Commission has recommended the establishment of a Bureau of Cyber Statistics (BCS). [read post]
2 Feb 2021, 10:00 pm
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on manufacturing considerations for certain cellular and gene therapy products during the COVID-19 pandemic. [read post]
2 Feb 2021, 10:00 pm
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on manufacturing considerations for certain cellular and gene therapy products during the COVID-19 pandemic. [read post]
2 Feb 2021, 10:00 pm
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on manufacturing considerations for certain cellular and gene therapy products during the COVID-19 pandemic. [read post]
2 Feb 2021, 10:00 pm
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on manufacturing considerations for certain cellular and gene therapy products during the COVID-19 pandemic. [read post]
2 Feb 2021, 10:00 pm
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on manufacturing considerations for certain cellular and gene therapy products during the COVID-19 pandemic. [read post]
2 Feb 2021, 10:00 pm
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on manufacturing considerations for certain cellular and gene therapy products during the COVID-19 pandemic. [read post]
