Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Suitability Petitions topic
No spam. Unsubscribe anytime.
Agency official explains suitability petitions, cross-referencing and NTI guidance for applicants
Summary
An FDA presenter described how suitability petitions and cross-referencing from approved strengths/formulations can be used in submissions, gave ODT and bupropion examples, and summarized specific PSG guidance for narrow therapeutic index drugs. The presenter stressed PSGs are advisory and applicants may propose alternatives.
At a workshop session, an FDA agency official walked through suitability petitions and how sponsors can use cross‑referencing to rely on approved products when supporting later submissions. The presenter used orally disintegrating tablets (ODT) and bupropion hydrochloride ER tablets as examples of when applicants might perform either two BE studies or, when an ODT is already approved, a single BE study using the approved ODT as the reference.
The presenter said the agency is adding suitability‑related information proactively to PSGs so applicants have options before a petition is approved. "So the 1st option is that, you're gonna do 2 BE studies for the, using the designated, RS for the tablet... the 2nd bullet point, it talks about how there's a 1 b study recommendations, using the, approved ODT as a dosage form," the presenter explained.
The official also noted PSGs provide specific recommendations for narrow therapeutic index (NTI) drugs and referenced a staff publication in ORS describing the agency's experience with NTI study design. Throughout, the presenter reiterated that PSGs are guidance and applicants may submit alternative approaches and supporting justification for FDA review.
The presenter closed by inviting the next speaker, Dr. Rajesh, and reiterated the agency's intention to update PSGs in response to submitted queries and evidence.
