Submissions

CHPA tracks FDA progress vs. OMUFA goals and activities referenced in legislation. These goals were negotiated between the Agency and Industry prior to the legislation and cover the 5-year period for OMUFA I (October 1, 2020 – September 30, 2025).

CHPA strongly encourages FDA to provide further clarity regarding the appropriate human factors information in premarket submissions that involve a change from prescription use to over-the-counter use and associated changes from a predicate device as compared to modifications to a sponsor’s own device.

CHPA and members of our Dietary Supplements Committee appreciate the opportunity to comment on the recently released Draft Guidance outlining FDA’s approach to food allergen labeling.

CHPA appreciates the opportunity to provide input for Agency consideration as it works to finalize the regulations for ACNU.

In general, members are very satisfied with the existing regulations for content on the PDP, and recommend that no additional guidance on this topic is needed.

This guidance provides information on providing electronic submissions to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act).