FDA Draft Guidance


Do you have metered dose inhaler (MDI) or dry powder inhaler (DPI) products in your prodcut offerings?  Are you considering adding these product types?  FDA draft guidance on MDI and DPI products has been distributed for comment.

Comments and suggestions regarding this FDA draft guidance document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments here. Comments must be submitted on or before June 18, 2018.  Submit written comments to the Division of Dockets Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. The docket number is FDA-2018-D-1098. For questions regarding this FDA draft guidance document contact (CDER) Richard Lostritto 301-796-1697.