ICR Documents

Supporting Statement A Document Date Uploaded 0389 and 0765 SSA consolidation 2018.pdf 02/10/2018 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded Expedited Programs for Serious Conditions - Drugs and Biologics; Guidance for Industry 0765 Nonsub Request Sept 2018.pdf Justification for No Material/Nonsubstantive Change 09/25/2018 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received