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FDA provided an update on the implementation of new accelerated approval authorities and emphasized that drugs approved under the pathway meet efficacy requirements.
To print this article, all you need is to be registered or login on Mondaq.com. In follow-up to our colleagues recent post about the newly implemented Medical Device Regulation ("MDR") in the European Union, this post will discuss some of the similarities between FDA's Clinical Decision Support ("CDS") Software Draft Guidance (together the "CDS Draft Guidance") and the MDR. While still in draft form, we note that FDA has signaled its intent to finalize the CDS Draft Guidance in 2021. STATUTORY FRAMEWORK Under the current CDS Draft Guidance, FDA first bases its ...