Numerous pharmaceuticals are approved and marketed based on the premise that they favorably change disease state-biomarkers. However, recent data has shown that altering the biomarkers indicative of disease does not necessarily translate to ameliorated health. In an...
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...
A recent post from MedPage Today describes the newly published FDA draft guidance entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” that will potentially improve the speed of drug development. The guidance...
The new FDA draft guidance issued last during the second week of November demonstrates that FDA does not want institutional review boards (IRBs) to lose their critical role in the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...
