While most of us old timers grew up with Therapeutic Equivalence (TE) after the passage of Hatch-Waxman, the newly released draft guidance on TE (here) should be a good primer or refresher for most interested parties. There may also be some things you did not know, like how a 505(b)(2) application can request a TE rating (which has come under criticism from industry because the petition process has taken so long or been ignored by the Agency), why some ANDAs might not have TE codes, or why tentatively approved products are not assigned TE codes.
The guidance is broken down into five basic sections:
- The Fundamentals of Therapeutic Equivalence
- Products Evaluated for Therapeutic Equivalence
- The Therapeutic Equivalence Coding System
- Revisions to Therapeutic Equivalence Evaluations
- Frequently Asked Questions
When read in conjunction with the Orange Book sections on TE, you will become an expert in no time flat. For those of you on the NDA side of the house, the draft guidance could provide answers to a lot of burning questions you may have about the assignment of TE codes. The Q&A section is particularly helpful as an aid to understanding some of the more complex issues associated with TE determinations. I’ve been involved in the process and discussions surrounding TE determinations since 1984 and found it a good read! Enjoy, and please reach out if you have any questions (firstname.lastname@example.org).