Guidance for Industry: ANDA Submissions - Prior Approval Supplements Under GDUFA
Title:
Guidance for Industry: ANDA Submissions - Prior Approval Supplements Under GDUFA
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM404441.pdf
Content:
This guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).