What are the proposed CRDH guidelines for the 2023 fiscal year, and why do they matter? How should you be thinking about them? Today\u2019s episode covers the newly-released guidelines and addresses important questions about these guidelines specifically and about the practice of releasing these guidelines in general.
Today\u2019s conversation is with regular guest Mike Drues. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies.
In this episode, you\u2019ll hear what Mike has to say about what\u2019s on the FDA\u2019s A-list and B-list for the fiscal year 2023, what isn\u2019t on the list but perhaps should be, and what differences exist between draft guidelines and final guidelines.
\u201cNot to be too arrogant here, but I\u2019m very proud of the fact many of the things that I\u2019ve done in submissions over the years, whether it\u2019s with AI or BioComp or other kinds of testing has actually gone into guidance for the future.\u201d
\u201cThat\u2019s why there\u2019s a guidance document database, so you and I don\u2019t have to memorize such esoteric trivia.\u201d
\u201cIt\u2019s really not FDA\u2019s job to help a company bring a product on the market.\u201d
\u201cAll guidance, indeed all regulation, is very evolutionary. It\u2019s a work in progress.\u201d
FDA Website: CDRH Proposed Guidance\u2019s for Fiscal Year 2023
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