The new Form FDA-356h was released in July 2023. The FDA’s expectation is that the newly revised form (which has an expiration date of March 31, 2026) should be utilized when submitting new drug applications, abbreviated new drug applications, and biologics license applications for human use. The new form can be downloaded from a link that can be found here.
Be certain to update any new submissions that you are making, e.g., original applications, supplements, amendments, etc. to include the new form. The new form now has four pages of fun-filled boxes to be ticked and lots of information to be filled out. Be certain to fill out the form completely to avoid any issues on filing. The website above also has instructions for properly filling out the new Form FDA356h. Enjoy!
