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In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo the FDA's approval process. Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
Glycopeptide antibiotics are a class of drugs of microbial origin that are composed of glycosylated cyclic or polycyclic nonribosomal peptides.Significant glycopeptide antibiotics include the anti-infective antibiotics vancomycin, teicoplanin, telavancin, ramoplanin, avoparcin and decaplanin, corbomycin, complestatin and the antitumor antibiotic bleomycin.
Class II: Devices that are cleared using the 510(k) process. Diagnostic tests, cardiac catheters, hearing aids, and dental amalgams are examples of class II devices. Class III: Devices that are approved by the premarket approval (PMA) process, analogous to a New Drug Application. These tend to be devices that are permanently implanted into a ...
FDA-licensed in 1998; Withdrawn in EU (2002), US (2006) Fosamprenavir: HIV ViiV Healthcare: Amprenavir pro-drug: 2003 (FDA), 2004 Foscarnet: Herpes: Pyrophosphate analogue DNA polymerase inhibitor: 1991 Ganciclovir (Cytovene) [9] Cytomegalovirus (CMV) [10] Competitive nucleoside analogue dGTP inhibitor 1988 Ibacitabine: Herpes labialis ...
The U.S. Food and Drug Administration has cleared Cresilon's gel to quickly control bleeding, the privately held company said on Thursday, potentially giving emergency medical technicians and ...
Previously, HIV was the only other sexually transmitted infection to have an FDA-approved at-home test. Other at-home STI tests are available through telemedicine companies and major pharmacy chains.
In December 2008, the U.S. Food and Drug Administration (FDA) declined to approve oritavancin without additional studies, and an EU application was withdrawn. [ citation needed ] In 2009, The Medicines Company acquired the development rights, completed clinical trials and submitted a new drug application to the FDA in February 2014. [ 26 ]