Today, the IEDC released the below press release: INDIANAPOLIS (Jan. 29, 2013) – Pearl IRB, LLC d/b/a Pearl Pathways, a life sciences product development and regulatory consultant company, announced plans today to expand its operations here, creating up to 38 new jobs...
The new FDA draft guidance issued last during the second week of November demonstrates that FDA does not want institutional review boards (IRBs) to lose their critical role in the clinical research process. The new guidance, issued in November 2012 entitled “IRB...
The Food and Drug Law Institute annual conference will be held on December 12-13, 2012 in Washington, DC. The two- day conference welcomes attorneys, litigators, regulators, compliance experts, consultants, and academics in the drug, medical devices, biologics, food...
Science Daily recently published an article about a new report being issued by the InterAcademy Council (IAC) and IAP to help promote global adherence to science values and ethics in research. “Humanity has placed its trust in science to solve many of the...
The Presidential Commission for the Study of Bioethical Issues, a government advisory panel, released a statement reinforcing the need for privacy protection for those who choose to submit their whole genome sequencing for the purpose of medical research. Genomes...
According to an article on Outsourcing-Pharma.com, a new study indicates that the regulation of clinical trials in other regions of the world is too rigorous, urging pharma firms and CROs to create designs that are universal. The article entitled, “Trial regulation in...
