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As early as March 2020, the World Health Organization (WHO), [2] European Medicines Agency (EMA), [3] US Food and Drug Administration (FDA), [4] and the Chinese government and drug manufacturers [5] [6] were coordinating with academic and industry researchers to speed development of vaccines, antiviral drugs, and post-infection therapies.
As of 2016, the EMA was roughly parallel to the drug part of the U.S. Food and Drug Administration (FDA), [53] but without centralisation. [54] The timetable for product approval via the EMA's centralised procedure of 210 days compares well with the average of 500 days taken by the FDA in 2008 to evaluate a product. [55]
EudraLex is the collection of rules and regulations governing medicinal ... European Medicines Agency; ... Title 21 of the Code of Federal Regulations (USA) Drug ...
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 ...
Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements. [5] [6]
Europe's drug regulator said on Friday South Korean drugmaker Celltrion's COVID-19 treatment can be considered for patients at high risk of severe illness, but added that the monoclonal antibody's ...
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Herpes Zoster: Guanosine analogue 1994 Fomivirsen: AIDS Anti-sense oligonucleotide: Anti-sense FDA-licensed in 1998; Withdrawn in EU (2002), US (2006) Fosamprenavir: HIV ViiV Healthcare: Amprenavir pro-drug: 2003 (FDA ...
FDA accepts Pfizer's (PFE) NDA for ritlecitinib for treating severe alopecia areata. The EMA also accepts the MAA for a similar patient population.