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The GSRS is a freely distributable software system provided through a collaboration between the FDA, the National Center for Advancing Translational Sciences (NCATS) and the European Medicines Agency (EMA). [1] The GSRS was developed to implement the ISO 11238 standard which is one of the core ISO Identification of Medicinal Product (IDMP ...
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]
The WHODrug Dictionary is an international classification of medicines created by the WHO Programme for International Drug Monitoring and managed by the Uppsala Monitoring Centre. [ 1 ] It is used by pharmaceutical companies , clinical trial organizations and drug regulatory authorities for identifying drug names in spontaneous ADR reporting ...
In addition to the member states there are currently 30 observers, including the World Health Organization (WHO) and the Taiwan Food and Drug Administration (TFDA). The EDQM's quality standards for medicines are published in the European Pharmacopoeia (officially abbreviated to Ph. Eur.), which is recognised as a scientific benchmark worldwide ...
6-(2-Aminopropyl)-2,3-dihydrobenzofuran (6-APDB, 4-Desoxy-MDA, EMA-3) is a stimulant and entactogen drug of the phenethylamine and amphetamine classes. [1] It is an analogue of MDA where the heterocyclic 4-position oxygen from the 3,4- methylenedioxy ring has been replaced with a methylene bridge .
Suzetrigine, sold under the brand name Journavx, is a medication used for the management of pain. [1] [2] It is a non-opioid, small-molecule analgesic that works as a selective inhibitor of Na v 1.8-dependent pain-signaling pathways in the peripheral nervous system, [3] [4] avoiding the addictive potential of opioids.
Gradient responsive drug delivery systems are stimulated to deliver therapeutics through contact with an endogenous chemical gradient. When the system comes into contact with its specific chemical gradient, increased concentration of the chemical can lead to the conformational change or degradation of a drug carrier to allow drug release.
New Drug Applications (NDA) for eteplirsen and a similar drug drisapersen were filed with the US Food and Drug Administration (FDA) in August 2015. [13] The Prescription Drug User Fee Act (PDUFA) goal dates for these were December 27, 2015 for drisapersen and February 26, 2016, for eteplirsen. Following FDA rejection of drisapersen, the agency ...