by Eagle Analytical | Dec 16, 2020 | COVID-19, FDA
FDA Authorizes the First At-Home COVID-19 Test Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral...
by Eagle Analytical | Nov 6, 2020 | All Posts, EagleTrax, FDA
FDA Finalizes Insanitary Conditions Guidance for Compounding Facilities The FDA has issued a statement with further emphasis on its intentions to increase enforcement against Insanitary conditions at compounding facilities. The statement comes after the FDA published...
by Eagle Analytical | Oct 28, 2020 | EagleTrax, FDA, Regulatory Info & Updates
What Do FDA Investigators Look For At Compounding Facilities? Recent FDA-483’s and Warning Letters reveal patterns of common observations by the FDA at compounding facilities. Did you know that you can find this information on fda.gov and get a head start in preparing...
by Eagle Analytical | Jul 15, 2020 | All Posts, COVID-19, FDA
Dexamethasone Sodium Phosphate Added to the List of Drugs for Temporary Compounding The FDA has added Dexamethasone Sodium Phosphate to the list of drugs for temporary compounding by outsourcing facilities and pharmacy compounders during the COVID-19 pandemic. This...
by Eagle Analytical | May 21, 2020 | All Posts, COVID-19, FDA
FDA Updates Guidance On Adverse Reporting During a Pandemic The FDA made an update to their final guidance, “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic”. The guidance document now includes...
by Eagle Analytical | May 15, 2020 | All Posts, FDA
Updates to FDA’s Purple Book: Database of Licensed Biological Products This week the FDA updated the Purple Book: Database of FDA-Licensed Biological Products. The update is part of a multi-phase enhancement of the database, intended to ultimately improve...
