NHeLP comments on Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”)

Executive Summary

The Orange Book is an important and informative drug resource for a range of stakeholders. In a request for comments, FDA seeks feedback on the types of people or entitles using the Orange Book, additional information and features to incorporate into the Orange Book, and therapeutic equivalence information. NHeLP comments offer a number of suggestions that would make the Orange Book more widely and readily accessible to the communities actually using the medications.