• Notice - Reconsideration of Decisions Issued for Human Drug Submissions
• Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant …
• Guidance Document: Fees for the Review of Veterinary Drug Submissions and Applications
• Notice - Draft Guidance Document: Administrative Processing of Drug Submissions and Applications …
• Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) …