- FDA will respond to comments seeking clarification on the process for obtaining therapeutic equivalence evaluations in a forthcoming guidance document.
- FDA clarified that petitioned ANDAs are expected to have the same therapeutic effect as the reference listed drug.
- Revisions to the discussion about what kind of information may be submitted in an ANDA seem to emphasize FDA’s “significant flexibility” on this issue.
As always, the devil is in the details. Much policy will be developed in the context of individual applications. For more information on how to strategically approach drug approval pathways (yours or a competitor’s), please contact any of the authors of this alert or the Hogan Lovells lawyer with whom you regularly work.
Authored by Philip Katz and George O'Brien