FDA provided an update on the implementation of new accelerated approval authorities and emphasized that drugs approved under the pathway meet efficacy requirements.
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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Clinical Decision Support ( CDS ) Software Draft Guidance (together the CDS Draft
Guidance ) and the MDR.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Draft Guidance in 2021.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Under the current CDS Draft Guidance, FDA first bases its
approach to CDS on criteria set forth in the 21st Century Cures Act