New Guidance From FDA Lays Bare Types Of Submissions That Must Be Filed Electronically
A short, seven-page draft guidance from the US agency lists submissions that must be sent to the FDA in an electronic format.
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The US agency’s new guidance doc lays bare the types of submissions device and drug makers should send to the agency electronically.
Amy Abernethy, FDA's principal deputy commissioner, sat down with Medtech Insight during CES 2020 to discuss the agency's progress on the Technology Modernization Action Plan, the pre-certification program for digital health products, and the FDA's plans for 2020.
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?