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Lapses in quality management systems and adverse event reporting topped the list of major deviations found during EU postmarking inspections last year: 18 sites were cited for QMS issues and 13 for problems with AE reporting. Read More
Drugmakers are seeking clarification on the use of in vitro studies to assess the effects of active pharmaceutical ingredients taken by men on their potential offspring. Read More
GlaxoSmithKline has temporarily closed its Zebulon, N.C., facility after routine testing found the bacteria that causes deadly Legionnaire’s disease inside two of the building’s external cooling towers. Read More
Proteon Therapeutics has enrolled its first patient in a second Phase 3 clinical study evaluating vonapanitase as a guard against vascular access failure in hemodialysis patients. Read More
A series of social media posts by reality TV star Kim Kardashian promoting Duchesnay USA’s morning sickness drug landed the company an FDA warning letter because no risk information was included. Read More
Drugmakers in Australia are urging the Therapeutic Goods Administration to raise the number of patients required for classifying an orphan disease, saying it would bring the threshold in line with the EU, Canada and Switzerland. Read More
GlaxoSmithKline, which last year paid Chinese authorities $483 million to settle corruption charges, is facing similar allegations in Romania. Read More