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FDA Alerts Consumers to Unauthorized Fraudulent COVID-19 Test Kits americanpharmaceuticalreview
March 25, 2020
The U.S. Food and Drug Administration (FDA) is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic ...
FDA Provides Update on Patient Access to Certain REMS Drugs during COVID-19 Public Health Emergency americanpharmaceuticalreview
March 24, 2020
As part of the U.S. Food and Drug Administration’s (FDA) ongoing efforts to address the coronavirus pandemic (COVID-19).
FDA Provides Access to Certain REMS Drugs contractpharma
March 24, 2020
New guidance allows sponsors and healthcare providers discretion regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing.
FDA Approves Spravato (esketamine) Nasal Spray for Treatment-Resistant Depression drugs
March 06, 2019
The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (t
Inappropriate Use of Fentanyl Preps Seen Despite Awareness drugs
February 20, 2019
Despite adequate levels of prescriber, pharmacist, and patient knowledge regarding transmucosal immediate-release fentanyls (TIRFs)....
FDA Determines Erythropoiesis-Stimulating Agents Risk Evaluation and Mitigation Strategy No Longer N americanpharmaceuticalreview
April 17, 2017
In 2017, the FDA determined that the ESA Risk Evaluation and Mitigation Strategy (REMS), In 2017, the FDA determined that the ESA Risk Evaluation and Mitigation Strategy (REMS).