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The data integrity issues most likely to lead to a delay in FDA marketing approval for new drugs include poor quality control for data entry, systemic errors at clinical study sites — such as enrolling ineligible patients — and database changes made after an initial database lock and study unblinding. Read More
A compounding operation in North Carolina landed an FDA warning letter for compounding drugs without prescriptions and for sterility concerns. Read More
The FDA is pressing a GlaxoSmithKline subsidiary to make a hard choice about operations at a U.K. plant: either decontaminate the whole facility to address repeated problems with penicillin contamination or else restrict production to penicillin. Read More
The FDA has handed Infusion Options a warning letter for a slew of GMP deficiencies in compounding sterile products and failing to meet 503B conditions for outsourced compounding operations. Read More