Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
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21 CFR 601.2 - Applications forbiologics licenses; procedures for filing(a) General. To obtain a biologics license…themanufacturer shall submit an application……and the address <strong>of</strong> each location involved in themanufacture <strong>of</strong> the biological product shall belisted in the biologics license application. Anapplication for a biologics license shall not beconsidered as filed until all pertinent informationand data have been received…10