FDA Officials Cite Reasons For Denying Application Reviews Over Data Integrity Breaches
Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.
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The agreement negotiated with FDA to resolve good manufacturing practice violations includes data integrity measures not commonly found in pharmaceutical GMP settlements, including auditing of almost all pending and approved drug applications and appointment of an independent data integrity expert.
Seven pharmacies have filed a lawsuit against the FDA claiming the agency exceeded its statutory authority in its final standard memorandum of understanding on interstate compounding and that the MOU will have an adverse impact on compounding pharmacies and patients.