FDA Warned of Removing Guidance Comment Period in Proposed Plan

The FDA’s consideration of a plan to eliminate public comment periods before implementing agency guidance sits on shaky ground with industry groups and legal experts, who say the move undermines public feedback.

The Food and Drug Administration drew resistance to its draft report and plan for best practices that laid out its intention to issue guidance documents without a notice and comment period.

The plan is in response to the 2023 federal spending law, which directs the FDA to issue a report identifying best practices for prioritization, development, issuance, and use of guidance documents. The FDA is proposing to issue ...