BRIEF — ANDA submission forms changed

The US Food and Drug Administration has updated the summary table forms for abbreviated new drug application (ANDA) submissions containing clinical endpoint studies.

Replacing the previous version are two separate documents, one for submissions containing comparative clinical endpoint bioequivalence studies, and another for submissions containing irritation/sensitization/adhesion studies specifically for transdermal and topical delivery systems.

Applicants should refer to the Clinical Data Interchange Standards Consortium for submitting electronic datasets for ANDA submissions.

The summary table forms for aqueous nasal spray products have also been updated.