Industry Protests FDA Plan To Clear Guidance Backlog By Skipping Comments

By Jessica Karins / March 27, 2024 at 2:21 PM
Key industry groups are objecting to FDA’s plan to tackle its decades-old backlog of draft guidance documents by sometimes skipping opportunities for public comment, and they offer a number of other ways the agency could overhaul its guidance procedures. While it made sense to sidestep public comments to expedite guidance during the COVID-19 pandemic, industry says, the practice shouldn’t carry over post-pandemic. Instead, stakeholders say the agency should overhaul its guidance practices by having the commissioner address intra-agency differences that...

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