With several COVID-19 vaccine candidates nearing Phase 3 readouts and the prospect that one or more could receive emergency use authorization (EUA) before the end of the year, advisors to the US Food and Drug Administration (FDA) met on Thursday to deliberate the standards the agency has set for authorization or licensure of a vaccine.
Posted: October 23, 2020, 10:19 pm
The European Commission (EC) is seeking public consultation on a new preliminary opinion on the potential association between breast implants and a type of lymphoma, with comments due by 7 December 2020.
Posted: October 23, 2020, 9:31 pm
In a recently released reflection paper, the European Medicines Agency (EMA) urged pharmaceutical manufacturers to consider the physical and cognitive abilities of patients age 65 years and older when developing products. Those considerations may impact everything from the dosage form to the package labeling.
Posted: October 23, 2020, 8:40 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: October 23, 2020, 8:10 pm
This article is about making the transition from company-based regulatory management to regulatory consultancy. It describes the differerences between the two roles and provides hands-on, detailed guidance on best practices and how to prepare and tool up for consulting. The author presents a case study demonstrating step by step how a consultant drew on those practices and tools to assist an overseas client in successfully marketing an existing medical device in the US.
Posted: October 23, 2020, 3:00 pm