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A Houston, Texas, API and finished drugmaker received an 11-observation Form 483 for a litany of cGMP violations, including failing to investigate complaints about caterpillars and poppy seeds in vials of finished product. Read More
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
The European Medicines Agency is planning to develop an EU portal and database as a single entry point for clinical trial data submissions by May 2016. Read More
The FDA on Tuesday issued final guidance clarifying when large drug compounding facilities must register with the agency, making only a few changes to a draft version released in February. Read More
A House Energy and Commerce Committee report on cybersecurity breaches at HHS blames the FDA for not acting forcefully enough to prevent a known web vulnerability that has been a security concern for the past decade. Read More