• Draft Guidance for Industry: Quality Guidance: Applications for Drug Identification Numbers (DINAs) …
• Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) …
• Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) …
• Preparation of veterinary Drug Identification Number submissions
• Electronic media in prescription drug labelling guidance: Submission and assessment