Top FDA Compliance Official Notes 'Revival' Of Data Integrity Fraud
A top FDA compliance official warns the generic drug industry of a “revival” of data integrity fraud as a number of brand-name drugs go off patent and companies rush to be the first to file.
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Poor data integrity at Asian API firms, poor quality programs at foreign OTC firms and poor sterility assurance at US compounding pharmacies were the main factors leading US FDA to issue 110 drug GMP warning letters in 2016, a huge increase from prior years. Article is first of four-part series in our annual analysis.
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