oral products / sterile products / process validation protocol / parenteral product / container closure systems / drug product / proposed manufacturing site / foreign sourced reference product / reference product / generic product / process equipment / sourced reference product / reference products / parenteral products / sterile product / manufacturing site / manufacturing site/process / proposed active pharmaceutical ingredient / manufacturing processes / /
Organization
Health Products and Food Branch / Federal Government / Therapeutic Products Directorate / General Chapter of the Ph. / ICH Authority / Therapeutic Goods Administration / European Union / Health Sciences Authority / United States Food and Drug Administration / /
Sponsor Attestation Checklist for Abbreviated New Drug Submissions (ANDS) and Supplements to an Abbreviated New Drug Submission (SANDS)