Eight months into FDA’s FY2018, let’s look at the progress they have made in achieving their guidance document issuance goals. CDRH published the guidance document prioritization list it intends to work from in FY18 here.
Three lists were provided:
1. A list of guidance documents that the Agency fully intends to publish (the "A-list");
2. A list of guidance documents that the Agency intends to publish as resources permit (the "B-list"); and
3. A list of final guidance documents that issued in 2008, 1998, 1988, and 1978 subject to focused retrospective review.
Should you have any questions, feel free to contact us.
Lorry Weaver Huffman, US Regulatory Affairs Expert
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