FDA Extends Comment Period for Inhaler Guidance Criticized by Industry Groups

The FDA reopened the comment period for its guidance on metered dose inhaler and dry powder inhaler drug products after receiving comments questioning the agency’s thinking in the draft.

The Association for Accessible Medicines  said sponsors have based their development plans and budget allocations on requirements outlined in the agency’s 1998 guidance, “making it difficult to retrospectively change course,” adding that the FDA “should provide clarity around its expectations for companies to comply with the new guidance and consider a suitable transition period, for example 2 years.”

Secondly, the AAM wrote, the FDA should clarify the distinction between its expectations for NDAs and ANDAs. To avoid confusion, the final guidance should make clear when specific requirements are only appropriate for NDAs.