Danish Regulator Offering Free Advice On How to Comply With New EU Regulations
The Danish Medicines Agency is testing a new regulatory advice service that medical device SMEs and start-ups anywhere in the world can apply to use.
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Zolgensma should receive a conditional approval, says the European Medicines Agency’s drug evaluation committee, the CHMP.
The health technology assessment institute is taking a virtual approach to meetings and has said that it can provide free fast-track advice for companies developing novel diagnostics or therapeutics for the coronavirus.
Companies are due to learn this week whether the European Medicines Agency will fast-track its review of their soon-to-be-filed EU marketing applications.