Guidance for Industry: ANDA Submissions - Prior Approval Supplements Under GDUFA
Titel:
Guidance for Industry: ANDA Submissions - Prior Approval Supplements Under GDUFA
Internet:
Herkunft/Verlag:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM404441.pdf
Inhalt:
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)).