• Regulatory NewsRegulatory News

    FDA finalizes guidance on pre-launch drug import policy

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance to assist sponsors in submitting requests to import unapproved finished drugs prior to market launch of a pending new drug application (NDA), abbreviated new drug application (ANDA) or biologics license applications (BLA).   The guidance outlines the procedures for making these requests under the agency’s Pre-Launch Activities Importation Requests (PLAIR) program and FDA’s timetable for approvi...