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16 September 2019
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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13 September 2019
The US Food and Drug Administration (FDA) is warning that breast cancer drugs Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) may cause rare but severe inflammation of the lungs that could lead to death.
13 September 2019
Last April, Sprout Pharmaceuticals completed postmarketing trials for its drug Addyi (flibanserin), which is used to treat decreased sexual desire in women, and the US Food and Drug Administration (FDA) said it could change the labeling of the dru...
13 September 2019
Following its investigation into an impurity called N-nitrosodimethylamine (NDMA) in blood pressure medicines, the European Medicines Agency (EMA) on Friday said that, at the request of the European Commission, it’s beginning a review of ranitidin...
12 September 2019
The UK government on Wednesday published a previously sensitive document explaining how a no-deal Brexit beginning on 31 October could strain trade across the English Channel for up to six months.
12 September 2019
The European Network of Pediatric Research at the European Medicines Agency (Enpr-EMA) on Thursday opened a public consultation on a draft framework for pediatric clinical trial preparedness.
12 September 2019
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released four final guidance documents on the Special 510(k) program, the abbreviated 510(k) program, how to format traditional and abbreviat...