by: Robert Brooks

Several stakeholders are raising issues related to an FDA docket on quality considerations for metered dose inhaler and dry powder inhaler products. The Association for Accessible Medicines, representing generic drug interests, voices three key concerns: industry should be granted a transition period to comply with the new requirements; the agency should clearly distinguish its expectations for NDAs and ANDAs as the draft guidance discusses each; and FDA should be clearer on the new stability requirements in the draft guidance. The association also submits line-by-line technical comments.

The International Pharmaceutical Aerosol Consortium on Regulation & Science says it supports the introduction of development approaches for orally inhaled and nasal drug products by using Quality by Design, risk management, and parametric tolerance interval testing (PTIT), and incorporation of combination product quality concepts. The group says the draft guidance would benefit significantly from revisions clarifying the agency’s expectations for incorporation of Quality by Design and risk-based approaches, regulatory alignment, application of the PTIT concept, and scope of guidance application and implementation.

A GlaxoSmithKline comment letter tells FDA that (1) its expectation and scope of the guidance are not clear; (2) there are inconsistencies within the document and also to regulations/other guidances on expectations; (3) some recommended testing is outside of normal practice or no longer necessary based on industry experience; and (4) greater clarity is needed regarding in vivo/in vitro correlation.

Finally, the Combination Products Coalition submitted line-by-line comments focused on the combination product aspects of the draft guidance and intention to provide suggestions to help align the draft with respect to development and registration expectations for those products as a whole and not only inhalers.