Some 50 healthcare-related associations ask the president and Congress to end the government shutdown and bring FDA back to full capacity.
FDA issues a guidance to help industry facilitate development and validation of assays to assess immunogenicity of therapeutic protein products during...
FDA denies an American Dental Association petition asking that the agency open rulemaking to revise five oral health OTC drug product monographs.
Bloomberg News says that drug company and trade association lobbying expenses hit new highs in 2018.
The Duke-Margolis Center for Health Policy examines artificial intelligence-enabled clinical decision software and FDAs regulatory role.
FDA clears an Imperative Care 510(k) for its line of neurovascular access catheters, which are intended to deliver interventional treatments during ne...
The Senate Finance Committee plans a 1/29 hearing on Drug Pricing in America: A Prescription for Change, Part I.
FDA slaps a clinical hold a Translate Bio IND submission for MRT5201 for treating ornithine transcarbamylase deficiency, due to additional clinical an...