This Week at FDA: Makary Teases Plan for Single-Trial Drug Approvals, Høeg Named Acting CDER Chief, and More
Article Summary: This week, FDA Commissioner Marty Makary announced the agency will shift its eviden…
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Biosimilars: Industry Seeks Enhancements for Next BsUFA
Article Summary: The US Food and Drug Administration (FDA) has made a significant decision to elimin…
FDA’s Top Drug Regulator Submits His Resignation
Article Summary: The FDA’s top drug regulator, Rick Pazdur, has submitted his resignation to t…