FDA commissioner Steve Hahn indirectly contradicts President Trump, telling ABC News that ramping up caronavirus testing, both diagnostic and new anti...
FDA allows the use of home-use blood glucose meters by patients with diabetes who are hospitalized due to COVID-19 to check their own blood glucose le...
Federal Register notice: FDA makes available two final guidances entitled Guidance on Chloroquine Phosphate and Guidance on Hydroxychloroquine Sulfate...
A just-published study report on the compassionate use of Gileads investigational remdesivir in Covid-19 patients shows improvement in oxygen-support ...
FDA posts a final guidance on developing and labeling In vitro companion diagnostic devices for oncology Products.
FDA grants BD an emergency use authorization for a molecular diagnostic test for Covid-19 that can return results in two to three hours.
FDA Review posts the Federal Register notices for the week ending 4/10/2020.