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August 24, 2018
FDA sent a warning letter to Kyowa Hakko Bio Co., Ltd. after inspectors found data integrity problems at the company’s Yamaguchi, Japan facility.
August 23, 2018
Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.
As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.
August 16, 2018
FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.
August 15, 2018
FDA published a resource guide to promote responsible opioid prescribing in the treatment of animals.
August 13, 2018
Westminster Pharmaceuticals, LLC is voluntarily recalling Levothyroxine and Liothyronine after FDA issues import alert affecting the active ingredient.
August 10, 2018
Only 54% of North Americans feel informed about the requirements of the general data protection regulation (GDPR), according to a report by GlobalData.
The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.
August 07, 2018
The agency issued a draft guidance on developing new medication-assisted treatments for opioid-use disorder.
August 02, 2018
Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework.