FDA Guidance for Industry: ANDA Submissions – Refuse-to-Receive Standards:Questions and Answers

Titel:
FDA Guidance for Industry: ANDA Submissions – Refuse-to-Receive Standards:Questions and Answers
Herkunft/Verlag:

FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM578368.pdf

Inhalt:
This draft guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and certain prior approval supplements (PASs) to ANDAs

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