• Guidance Document: Reconsideration of Decisions Issued for Human Drug Submissions and Natural …
• Policy Issues: Filing of Supplemental New Drug Submissions, Supplemental Abbreviated New Drug …
• Notice - Draft Guidance Document: Administrative Processing of Drug Submissions and Applications …
• Notice - Updated Screening Criteria for Generic Drug Submissions
• Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant …