Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products - Proposed Rule

OMB 0910-0794

Latest Forms, Documents, and Supporting Material

Document Name
SUPPORTING STATEMENT EDL PR FINAL 1 5-28-15.doc Supporting Statement A
Distribution of Prescribing Information by Fax, Email, or Mail When Requested
Production of New Label Statement on Immediate Container Label or Outside Package (Web site and Toll-Free Number)
Submission of Circular of Information by Blood Establishments
Review for Accuracy and Completeness of Posted Prescribing Information
Requests to Receive Prescribing Information by Fax, Email, or Mail When Requested
Requests for Exemptions
Review of Accuracy of Posted Labeling and Circular of Information
Submission of Updated Labeling and Circular of Information