FDA Guidance for Industry: ANDA Submissions – Refuse-to-Receive Standards:Questions and Answers
Title:
FDA Guidance for Industry: ANDA Submissions – Refuse-to-Receive Standards:Questions and Answers
Origin/Publisher:
FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM578368.pdf
Content:
This draft guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and certain prior approval supplements (PASs) to ANDAs