FDA published the ICH Q11 Drug Substance Q&A developed to clarify the principles for selecting starting materials described in ICH’s 2012 guidance. The Q&A provides additional clarification and promotes convergence on the selection and justification of starting materials for chemical entity drug substances, and provides recommendations on the relevant information that should be provided in marketing authorization applications and/or master files. Comments may be submitted at any time.
INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
