Regulatory Open Forum

Hello  All,

Good morning..

For NDA product , we are planning to submit ANDA. But there is no PSG for BE study. we have submitted CC to FDA , FDA asked we need to check PSG fda portal for updates.

Now we can see FDA listed in upcoming guidance list but for that we have to wait for more than a year (2024 tentative).

Please suggest suitable way to move forward.

Regards,

sapna

You can always request a Type C meeting with OGD for guidance.