Facility Readiness:
Facility readiness pertains to the state of preparedness of manufacturing facilities involved in producing generic drugs.
Goal Date Decisions:
Goal date decisions refer to the FDA's commitment to review and decide on generic drug applications within specific timelines agreed upon under the GDUFA program.
In essence, facility readiness and goal date decisions under GDUFA are integral to maintaining high standards of manufacturing quality and efficiency in the approval of generic drug applications, ultimately contributing to improved patient access to affordable medications.