Draft Guidance Proposes Longer Stability Testing for Generics

A draft guidance on abbreviated new drug application (ANDA) stability testing could require 6 months of testing rather than the 3 currently required. The draft guidance is available through the FDA website, and is open to written and electronic comments.

In addition, the current standards date from 1995 and allow stability studies to be conducted based on long-term room temperatures. This guideline is no longer adequate to determine the stability of new drug compounds, the FDA stated.

Instead, the draft recommendations suggest following the International Conference on Harmonization guidances Q1A through Q1F, which pertain to new drug approvals. If accepted, the guidance would require generic manufacturers to submit data from 3 pilot drug batches or 2 pilot drug batches and a small-scale drug batch. At the time of submission, companies should provide 6 months of accelerated and long-term condition data, as well as submitting multiple lots of drug components.

In addition, the draft guidance would require manufacturers to submit a fully packaged exhibit batch, use 3 drug batches when analyzing for manufacturing variability, and provide a statistical analysis of the data, where appropriate.