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The FDA will convene a public meeting of its Pediatric Advisory Committee to discuss the use of opioid cough medicines in treating children, part of the agency’s ongoing efforts to address this issue, FDA Commissioner Scott Gottlieb said Aug. 21. Read More
German health officials called for a ban on imports to the European Union from a plant operated by Dr. Reddy’s Laboratories in India, following inspections finding poor quality controls, dirty equipment, and other shortcomings. Read More
The FDA is soliciting comments from industry members and shareholders on how direct-to-consumer drug advertising should depict risk information. Read More
A company that warehouses drugs but doesn’t own them fits into a new category to be regulated under a 2013 federal law that aims to tighten security over the drug supply chain by 2023, according to new FDA guidance released Aug. 18. Read More
In 2015, the government asked drug manufacturers to submit self-assessments to state authorities, but CDSCO said it hasn’t received any reports. Read More