Bayer AG and Elsevier studied more than 1.6m adverse events to show how big data can be used to reduce animal testing and design trials "altered to potential risks," says researcher.
President Trump says he will sign the “big legislation” after the US House of Representatives passed the Right to Try Act – opponents of which warn lacks key patient protections.
Glenmark Pharmaceuticals has suspended a Phase II clinical trial at a site in India following media reports that villagers were allegedly “deceived” into participating.
IQVIA has been contracted to expand the safety and efficacy monitoring of biologic products as part of a novel alliance with the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER).
Revisions to the Federal Policy for the Protection of Human Subjects has been delayed six months, possibly more, as regulators cite the rule’s complexity, lack of guidance, and other challenges.
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recently established a new advisory council devoted to patient engagement.
The US Food and Drug Administration (FDA) has released a new draft guidance as part of its stated commitment to assist sponsors and expedite drug development for rare pediatric diseases.
WIRB Copernicus Group (WCG) has expanded its portfolio of companies to include the pharmacovigilance and drug safety solution provider Vigilare International.
As the industry continues to externalize components of the supply chain, global regulatory authorities are requiring a “quality-by-design” (QbD) approach to help mitigate risk across the drug development process.
ICON and the International Consortium for Health Outcomes Measurement's (ICHOM) pilot patient outcomes platform – known as ‘Globe’ – aims to improve drug development procedures.
