The US Food and Drug Administration’s drugs center is working to standardize how it decides to bring an application to an advisory committee, as well as the background materials and questions for those meetings.
Advisory Committees: US FDA Standardizing Decisions On When To Vet Applications
Center for Drug Evaluation and Research also is trying to ensure that questions posed at advisory committee meetings are written in clear and consistent language.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.