The European Medicines Agency is getting stricter with companies who ask for more time to deal with the questions and issues raised by the agency while reviewing their new drug marketing authorization applications (MAAs) via the centralized procedure.
Key Takeaways
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The European Medicines Agency is concerned that companies are requesting for longer clock-stops to respond to questions regarding their drugs under review.
A new template has been introduced to ensure that all requests for “extended clock-stops” by MAA applicants are “well justified.”...
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