Global Medtech Guidance Tracker: February 2020
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifteen guidance documents have been posted on the tracker since its last update.
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The US FDA on 29 February issued a new guidance giving the OK to labs with pending COVID-19 laboratory-developed tests (LDTs) to use them while they await the agency’s approval under Emergency Use Authorization. The agency issued the guidance quickly, taking the unusual step of forgoing a public comment period.
The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions.
Austria may not be part of an important monkeypox clinical trial taking place in several European Economic Area countries, but discussions on the study made the Austrian regulator realize its limitations in undertaking fast-track evaluations under the EU Clinical Trial Regulation.