The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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The FDA Group's Insider Newsletter
The FDA Group's Insider Newsletter
Implementing ICH Q14’s Enhanced Approach to Analytical Method Development, FDA's Proposed Framework for Human Factor Info in Device Submissions + Warning Letter Breakdown
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Implementing ICH Q14’s Enhanced Approach to…

The FDA Group
Mar 3, 2023
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The FDA Group's Insider Newsletter
The FDA Group's Insider Newsletter
Implementing ICH Q14’s Enhanced Approach to Analytical Method Development, FDA's Proposed Framework for Human Factor Info in Device Submissions + Warning Letter Breakdown
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Watch now (46 min) | We explore FDA's new list of alternative ways to comply with cGMP requirements for combo products, dissect a new draft guidance for device companies, and break down a Warning Letter.

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