Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
Food and Drug Administration
Eligibility
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.The FDA will not accept duplicate or highly overlapping applications under review at the same time. This means that the FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.•A resubmission (A1) application that is submitted before issuance of the summary statementfrom the review of the previous new (A0) application.