Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers." It replaces the draft guidance with the same name that published on August 27, 2013 (78 FR 52931). This guidance clarifies stability testing recommendations discussed in International Conference on Harmonisation (ICH) stability guidances Q1A(R2) through Q1E for abbreviated new drug applications (ANDAs) and provides responses to public comments in a questions-and-answers format.