Industry Protests FDA Plan To Clear Guidance Backlog By Skipping Comments

Key industry groups are objecting to FDA’s plan to tackle its decades-old backlog of draft guidance documents by sometimes skipping opportunities for public comment, and they offer a number of other ways the agency could overhaul its guidance procedures.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...