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FDA Publishes New Filing Checklists to Prevent Drug Submission Delays

1 day ago talkbio0Tagged Abbreviated New Drug Application, Complete Response Letters, drug application, filing checklist, New Drug Application, regulatory guidance, submission delays, United States Food and Drug Administration

FDA; filing checklist; drug application; submission delays; New Drug Application (NDA); Abbreviated New Drug Application (ANDA); Complete Response Letters; regulatory guidance