PhRMA calls on FDA to make changes to a draft guidance on demonstrating biologic interchangeability with a reference product.
An FDA inspection at a third-party manufacturer cites inspection issues that have resulted in a complete response letter on a Regneron BLA for a multi...
FDA publishes the International Council for Harmonization E11A guidance intended to recommend and harmonize pediatric extrapolation in developing new ...
FDA clears the Nanox HealthCCSng V2.0 artificial intelligence coronary solution to help detect coronary artery calcium.
An FDA report on bioresearch monitoring FY 2023 metrics documents nearly 1,100 inspections through FDAs five Centers.
The United States Court of Appeals for the DC Circuit grants a Novartis motion to stay FDAs approval of MSN Laboratories generic version of Novartiss ...
The Federal Trade Commission says it supports an FDA draft guidance easing the approval requirements for interchangeable biosimilar drugs.
The Government Accountability Office says FDA has faced challenges in its preparations for beginning active postmarket surveillance of medical devices...
