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Sponsors with pending NDAs and ANDAs backed by trials conducted at India’s Semler Research Limited must return to the drawing board because of data integrity issues, the FDA said. Read More
The National Institutes of Health has suspended production at two of its facilities following an investigation last year that found a National Cancer Institute laboratory conducting cell therapy production and a National Institute of Mental Health facility producing positron emission tomography materials, were not GMP-compliant. Read More
Pharmacy benefit manager Express Scripts is firing back at Anthem’s $15 billion lawsuit that accuses the PBM of breaching good faith negotiation requirements. Read More
The FDA has a slate of new recommendations companies should follow when submitting a comparability protocol assessing changes to the chemistry, manufacturing or controls of a drug or biologic after the agency has approved its production process. Read More
The list of Chinese pharmaceutical companies in the FDA’s crosshairs keeps on growing, with the agency hitting two drugmakers for GMP violations and another for refusing an inspection. Read More
A second FDA inspection of niche drugmaker Sri Krishna in almost 10 years has turned up a bevy of complaints regarding the company’s quality control systems and the accuracy of its data. Read More