Companies can get the European Medicines Agency’s scientific opinion for their products’ use in EU and non-EU countries at about the same time.
The European Medicines Agency has issued new guidance for companies interested in applying for the parallel evaluation of their medicines or vaccines meant for the EU-wide market as well as for non-EU countries under the so-called Article 58 procedure.
The parallel assessment would result in the EMA’s human medicines evaluation committee, the CHMP, adopting a scientific opinion in relation...
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
