Remote manufacturing assessments: FDA revises draft guidance to include newly expanded powers

The FDA on Fri­day re­leased new­ly re­vised Q&A guid­ance on how the agency can use vol­un­tary and manda­to­ry re­mote reg­u­la­to­ry as­sess­ments to bet­ter un­der­stand bio­phar­ma man­u­fac­tur­ers and to help sup­port ap­proval de­ci­sions.

While the agency makes clear that re­mote reg­u­la­to­ry as­sess­ments (RRAs) are not in­spec­tions, the re­vised guid­ance, orig­i­nal­ly is­sued in Ju­ly 2022, ex­plains new­ly added FDA pow­ers from a spend­ing bill in 2022, as well as how such as­sess­ments can pre­cede, prompt or be a fol­low-up to an in­spec­tion.

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