The EU and US have agreed to recognize drug and API manufacturing plant inspections conducted in their respective territories under a deal signed this week.
Wacker Biosolutions says an excipient shown to increase the bioavailability of a food supplement by a factor of 40 could have implications in the API space.
UDG’s Ashfield division will use Salesforce Health Cloud to help outsource clients launch therapies into EU and US markets through “seamless” data exchange.
The Trump administration is looking to massively reduce regulations – which could have major implications for pending guidelines that look to increase clinical trial patient safety.
Particulate problems in sterile injectables and poor aseptic techniques landed Pfizer with a US FDA warning letter at a former Hospira facility in Kansas.
Lab staff at an API plant run by Chongqing Pharma Research Institute Co., Ltd. deleted out of spec test results according to the US Food and Drug Administration (FDA).
Pharmaron has acquired a majority stake in Shin Nippon Biomedical Laboratories Clinical Pharmacology Center, continuing its strategy of becoming a full service R&D service provider.
