IMARC Research, a contract research organization (CRO) recently published a list of the “Top Five FDA Warning Letter Findings for Clinical Investigators.” Warning letters are issued when FDA finds objectionable conditions upon inspection. IMARC’s top 5 noted...
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...
In November 2012, the FDA published a draft guidance, entitled “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is Needed,” which outlines recommendations for the...
A recent post from MedPage Today describes the newly published FDA draft guidance entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” that will potentially improve the speed of drug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The new FDA draft guidance issued last during the second week of November demonstrates that FDA does not want institutional review boards (IRBs) to lose their critical role in the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...
