FDA releases a guidance entitled Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency.
FDA Review posts product approval summaries for the week ending 3/20/2020.
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 notice: FDA permanently debars Gerald Tighe from providing services related to an approved or pending drug product application.
Federal Register notice: FDA permanently debars Brenda Elise Edwards from providing services in any capacity to a person that has an approved or pendi...
FDA issues two guidance documents to communicate its policy for temporary manufacturing of certain alcohol-based hand sanitizer products.
FDA issues a new policy that allows manufacturers of certain FDA-cleared vital sign-measuring devices to expand their use for healthcare providers to ...