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
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

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