Answers are provided to the questions regarding the stability of generics with regard to the following aspects:
General requirements on stability data
Stability data in the Drug Master File
Stability and packaging: various dosage forms
Amendments to pending ANDA applications
In the following, you can see the position of the FDA regarding certain stability issues illustrated by some examples:
Question: When do intermediate stability studies need to be initiated in the event of failure at accelerated condition? Answer: We recommend starting intermediate stability, accelerated, and long-term studies at the same time so the data are available at the time of submission, if needed.
Question: During the review cycle, will the application need to be updated with 12 months of long-term data? Answer: Yes. FDA will grant a proposed expiry period of two times the available long-term data at the time of approval, i.e. up to 24 months. This approach is due to the ICH Guideline Q1E "Evaluation of Stability Data" and the decision tree contained in Appendix A.
Question: Is it acceptable to submit the stability data of only two pilot scale batches of the finished product of a simple dosage form? Answer: No. The requirements of the stability Guidance have to be fulfilled for all dosage forms.
Question: When a patent is due to shortly expire and there are no approved ANDAs, can we file with 3 months stability data with a commitment to supply 6 months data when available? Answer: No. ICH stability guidances should be followed. 6 months of accelerated data are recommended at the time of filing the ANDA.
This Q&A document itself has a "Draft Guidance" status. Comments regarding the document should be submitted to the eRulemaking programme.