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Vital Laboratories failed to report production deviations, perform proper product reviews or take needed corrective actions at its Gujarat, India, facility, the FDA said in a warning letter. Read More
An EU regulation meant to boost pediatric drug development has led to more medicines for children since it was adopted, although actual use of new products has not increased at the same pace, a European Commission report said. Read More
The FDA issued a new draft guidance for sponsors developing treatments for gastroesophageal reflux disease in infants, children and adolescents — outlining clinical trial design considerations and the agency’s current thinking on extrapolating data in pediatrics. Read More
John Kapoor, founder and majority owner of Insys Therapeutics, was arrested and charged with bribery and fraud in the illegal distribution of a fentanyl spray, an opioid intended to treat pain in cancer patients. Read More
President Donald Trump officially declared the nationwide opioid crisis a public health emergency Thursday, directing agencies to use existing authority to the best of their ability to combat the epidemic. Read More