Risk-Based Inspections Might Actually Be Hurting Compliant Firms
Industry exec asks FDA to help good manufacturers prove to other countries they continue to meet GMPs even if they are not inspected frequently.
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Talks continue to include ANDA review times and metrics, increasing potential for more changes.
Sponsors say transparency is important as generic drug user fee negotiations move to inspection policy.
FDA will focus on enforcing quality standards, but remains aware of its indirect influence on pricing.