FDA Guidance for Industry: ANDA Submissions – Refuse to Receive for Lack of Justification of Impurity Limits

Titel:
FDA Guidance for Industry: ANDA Submissions – Refuse to Receive for Lack of Justification of Impurity Limits
Herkunft/Verlag:

FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM414598.pdf

Inhalt:
This guidance is intended to assist applicants preparing to submit to the Food and Drug Administration (FDA) original abbreviated new drug applications (ANDAs) and prior approvalsupplements (PASs) to ANDAs for which the applicant is seeking approval of a new strength of the drug product

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