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The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
The FDA issued warning letters to seven companies for selling products that claim to prevent, treat or cure COVID-19 caused by the new coronavirus.
The U.S. Food and Drug Administration has officially approved remdesivir as a treatment for coronavirus, drug manufacturer Gilead Sciences announced Thursday. The Ebola drug was already being used ...
COVID-19: Shionogi: 3C-like protease inhibitor Entecavir: HIV NRTI 2005 Etravirine (Intelence) [8] HIV NNRTI 2008 Famciclovir: Herpes Zoster: Guanosine analogue 1994 Fomivirsen: AIDS Anti-sense oligonucleotide: Anti-sense FDA-licensed in 1998; Withdrawn in EU (2002), US (2006) Fosamprenavir: HIV ViiV Healthcare: Amprenavir pro-drug: 2003 (FDA ...
[52] [53] [54] As of July 2021, a large number of drugs had been considered for treating COVID-19 patients. [55] As of November 2022, there was moderate-certainty evidence suggesting that dexamethasone, and systemic corticosteroids in general, probably cause a slight reduction in all-cause mortality (up to 30 days) in hospitalized patients with ...
The U.S. Federal Drug Administration (FDA) approved testing pooled samples to help speed up the coronavirus detection process and conserve supplies. The FDA reissued an existing emergency use ...
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...
Others wanted to register test kits with the U.S. Food and Drug Administration without approval from the manufacturer, or to offer home-based tests, which are not allowed by the FDA.