Federal Register notice: FDA issues two priority review vouchers to the sponsors of recent rare pediatric disease product applications.
FDA publishes a draft guidance with information for sponsors who are developing certain local anesthetic drug products to produce postoperative analge...
PhRMA suggests changes to an FDA revised draft guidance on the content and format of the Dosing and Administration section of drug labeling.
FDA revises the fact sheets on Janssens Covid-19 vaccine to include a warning about reported adverse events that suggest increased risks of myocarditi...
FDA clears a TytoCare 510(k) for its Tyto Insights for Wheeze Detection, an algorithm for use on the companys existing artificial intelligence-powered...
FDA warns Orlando, FL-based Profounda about CGMP violations in its production of finished drugs as a contract manufacturer.
House Select Subcommittee on the Coronavirus Pandemic Republican leaders ask FDA for communications and interviews relating to potential political int...
Four stakeholders provide additional information to the U.S. Patent and Trademark Office about its collaboration with FDA.
