Drug Quality Focus On Asia, OTCs Supported By New US FDA Data
OTCs and other "no-application" products remain a drag on overall quality, agency finds in annual quality report, while India and China continue to pose challenges.
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XGBoost model sees site complexity contributes to quality risk, but misses device-related issues, says third FDA pharmaceutical quality report.
The poorest-quality pharmaceuticals consumed in the US are the ones FDA has never reviewed, or are from sites the agency has never inspected, regardless of country of origin; the agency’s inaugural ‘State of Quality’ report contains some surprising findings.
Later this year, FDA expects to complete initial inspections of every facility that manufactures drugs for the US market. As the agency visits under-the-radar facilities recently targeted as part of an effort to leave no site uninspected, it is finding that they are more likely to have serious drug GMP issues.