[ Price : $8.95]
An FDA inspection at a third-party manufacturer cites inspection issues that have resulted in a complete response letter on a Regn...[ Price : $8.95]
FDA publishes the International Council for Harmonization E11A guidance intended to recommend and harmonize pediatric extrapolatio...[ Price : $8.95]
FDA clears the Nanox HealthCCSng V2.0 artificial intelligence coronary solution to help detect coronary artery calcium.[ Price : $8.95]
An FDA report on bioresearch monitoring FY 2023 metrics documents nearly 1,100 inspections through FDAs five Centers.[ Price : $8.95]
The United States Court of Appeals for the DC Circuit grants a Novartis motion to stay FDAs approval of MSN Laboratories generic v...[ Price : $8.95]
The Federal Trade Commission says it supports an FDA draft guidance easing the approval requirements for interchangeable biosimila...[ Price : $8.95]
The Government Accountability Office says FDA has faced challenges in its preparations for beginning active postmarket surveillanc...[ Price : $8.95]
Four House Democrats and Republicans urge FDA to take a greater role in protecting U.S. national security interests that could be ...