The FDA and EMA have completed the first collaborative assessment of a critical oncology biologic, with the agencies reviewing and approving a proposal to add new manufacturing and quality control…

The collection, use and submission of patient experience data (PED) still requires significantly more FDA guidance, clarification and support, big-name sponsors told the agency in response to a request for…

Friday, Biogen announced that it was planning to acquire Reata for approximately $7.3 billion, while Alexion, AstraZeneca’s rare disease subsidiary, announced that it had entered a purchase and license agreement…

This week, three medical devices used for cardiac issues were deemed class I by the FDA, the most serious type of recall, as use of the device may cause serious…

The Senate Finance Committee has advanced a bill seeking to reform pharmacy benefit managers (PBMs) by prohibiting them from deriving compensation for Medicare Part D-covered drugs based on the drug’s…

HHS announced plans to issue several FDA-related proposed and final rules in the coming year in its semiannual inventory of rulemaking actions. Source: Drug Industry Daily

Over the past week, the FDA issued final guidance for deoxyribonucleic acid (DNA) reactive impurities in pharmaceuticals, assessing biosimilar user fees, hydrogen peroxide-based contact lens products and CDER’s program for…

Listen to an audio podcast of the May 11, 2023, FDA Drug Safety Communication on warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions…