Human Drugs
Trump Doubles Down on Off-label Malaria Drug
President Trump continues promoting the malaria drug chloroquine for immediate off-label use to combat the coronavirus.
Human Drugs
Insulin, Other Biologics Transition to New Pathway
FDA says today (3/23) is the first day that insulin and certain other biologic drugs transition to a different regulatory pathway.
Guidance on REMS Testing During Virus Outbreak
FDA releases a guidance entitled Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency.
Medical Devices
Point-of-Care Coronavirus Test Authorized
FDA issues an emergency use authorization for Cepheids point-of-care coronavirus diagnostic, the Cepheid Xpert Xpress SARS-CoV-2 test.
Human Drugs
Genentech Phase 3 Actemra Trial for Coronavirus
FDA green lights a Genentech randomized, double-blind, placebo-controlled Phase 3 clinical trial in collaboration with the Biomedical Advanced Researc...
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 3/20/2020.
FDA General
Since Our last Issue...
Industry news you may have missed since our last issue.
Federal Register
FDA Permanently Debars Kalinoski on Filthy Drugs
Federal Register notice: FDA permanently debars Stephen Kalinoski from providing services in any capacity to a person that has an approved or pending ...
Federal Register
Tighe Permanently Debarred by FDA
Federal Register notice: FDA permanently debars Gerald Tighe from providing services related to an approved or pending drug product application.
Federal Register
Edwards Permanently Debarred by FDA
Federal Register notice: FDA permanently debars Brenda Elise Edwards from providing services in any capacity to a person that has an approved or pendi...
