GPhA Questions Use of ICH Guidance in ANDA Stability Testing Requirements

The Generic Pharmaceutical Association (GPhA) is questioning the FDA’s use of an International Conference on Harmonisation (ICH) guideline to specify ANDA testing requirements when it was originally intended for new drug substances and products. According to the GPhA, the U.S. industry and other stakeholders did not participate in creating the ICH stability guideline Q1A, which is what the FDA is basing its draft guidance on.
Washington Drug Letter