FDA will continue to use remote inspection tools to assess pending applications
FDA issues guidance on pre-approval plant inspections: The FDA will continue to use “alternative tools” such as remote interactive evaluations to assess compliance with good manufacturing practices in support of new drug, abbreviated new drug and biologics license approval applications, according to draft guidance formalizing the Agency’s inspection strategy. Factors the agency will consider when deciding whether remote or onsite inspection is appropriate include inspection history, product type, and feasibility of in-person inspection.