ICR Documents

Document Date Uploaded
01/12/2021

Document Date Uploaded

Title Document Document Type Date Uploaded
NDA Data Submission Agreement Tracked Changes Supplementary Document 08/15/2019
NDA Data Use Certification Tracked Changes Supplementary Document 08/15/2019
PIA Supplementary Document 10/07/2020
List of Consultants Supplementary Document 10/07/2020
30-day FRN Supplementary Document 10/19/2020
NDA Data Use Certification Tracked Changes Supplementary Document 02/24/2021
Attachment A Revised tracked changes of DSA Supplementary Document 10/20/2021
NDA Change Request Memo Justification for No Material/Nonsubstantive Change 08/15/2019
NDA Change Request Memo Justification for No Material/Nonsubstantive Change 02/24/2021
Change Request Memo Justification for No Material/Nonsubstantive Change 10/20/2021

Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received