FDA Guidance for Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
Titel:
FDA Guidance for Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
Internet:
Herkunft/Verlag:
FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM578366.pdf
Inhalt:
This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit or an applicant that has submitted an abbreviated new drug application (ANDA) for a complex product to FDA as defined in this guidance