www.fdanews.com/articles/159823-gpha-targets-fdas-anda-stability-guidance-saying-it-raises-new-questions
GPhA Targets FDA’s ANDA Stability Guidance, Saying it Raises New Questions
October 30, 2013
GPhA is asking for more clarification on the FDA’s recent guidance, Abbreviated New Drug Applications; Stability Testing of Drug Substances and Products: Questions and Answers.
Regulatory Focus
Regulatory Focus