FDA Guidance for Industry: ANDA Submissions – Refuse-to-Receive Standards
Titel:
FDA Guidance for Industry: ANDA Submissions – Refuse-to-Receive Standards
Internet:
Herkunft/Verlag:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM370352.pdf
Inhalt:
This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to ANDAs for which the applicant is seeking approval of a new strength of the drug product