Remote manufacturing assessments: FDA revises draft guidance to include newly expanded powers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.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.