The FDA published notices on February 16, 2016 announcing publication of draft guidances titled “Allergic Rhinitis: Developing Drug Products for Treatment” and “Nonallergic Rhinitis: Developing Drug Products for Treatment. The agency says that comments should be submitted by April 18, 2016 for either draft guidance in order to be considered prior to the start of work on a final draft.
The new allergic rhinitis draft guidance, which covers both seasonal allergic rhinitis and perennial allergic rhinitis, is a revision of a previous draft guidance titled, “Allergic Rhinitis: Clinical Development Programs for Drug Products,” which was published in 2000.
Read the FDA notice of availability for the allergic rhinitis guidance.
Read the draft guidance for allergic rhinitis.
Read the notice of availability for the nonallergic rhinitis guidance.
