FDA Adds 7 New Tools To Its Regulatory Science Toolbox
The US agency has updated its Catalog of Regulatory Science Tools.
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The regulatory tools are for use in medical device development.
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?