Regulatory Open Forum

Dear all,

As per ANDA RTR guidance: https://www.fda.gov/media/86660/download, Page 9 - Inadequate Stability:

"FDA will RTR an ANDA if certain batch size and study recommendations are not satisfied. The applicant should provide three pilot-scale batches or two pilot-scale and one small-scale batch with both accelerated and long-term data provided for each batch covering a period of no less than 6 months (180 days)"

My questions are:

Since FDA indicated the exact number of days (180):

1. Considering common practice, there will always be constrains for pull-out time (holidays, weekends, manpower, etc.). Therefore, the 180 days can be earlier or later than planned.
   Is there any allowed tolerance from this 180 days?

1. The guideline is dealing with ANDA submissions. Is it also expected for NDA's?

Thank you for your assistance.

No less than 6 months is strictly followed at OGD but not NDA since they may have exceptions due to BTD, Fast Track etc. The only possibility is if the generic drug falls under critical shortage list

Dear all,

As per ANDA RTR guidance: https://www.fda.gov/media/86660/download, Page 9 - Inadequate Stability:

"FDA will RTR an ANDA if certain batch size and study recommendations are not satisfied. The applicant should provide three pilot-scale batches or two pilot-scale and one small-scale batch with both accelerated and long-term data provided for each batch covering a period of no less than 6 months (180 days)"

My questions are:

Since FDA indicated the exact number of days (180):

1. Considering common practice, there will always be constrains for pull-out time (holidays, weekends, manpower, etc.). Therefore, the 180 days can be earlier or later than planned.
   Is there any allowed tolerance from this 180 days?

1. The guideline is dealing with ANDA submissions. Is it also expected for NDA's?

Thank you for your assistance.

Dear all,

As per ANDA RTR guidance: https://www.fda.gov/media/86660/download, Page 9 - Inadequate Stability:

"FDA will RTR an ANDA if certain batch size and study recommendations are not satisfied. The applicant should provide three pilot-scale batches or two pilot-scale and one small-scale batch with both accelerated and long-term data provided for each batch covering a period of no less than 6 months (180 days)"

My questions are:

Since FDA indicated the exact number of days (180):

1. Considering common practice, there will always be constrains for pull-out time (holidays, weekends, manpower, etc.). Therefore, the 180 days can be earlier or later than planned.
   Is there any allowed tolerance from this 180 days?

1. The guideline is dealing with ANDA submissions. Is it also expected for NDA's?

Thank you for your assistance.