A recent post from MedPage Today describes the newly published FDA draft guidance entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” that will potentially improve the speed of drug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The new FDA draft guidance issued last during the second week of November demonstrates that FDA does not want institutional review boards (IRBs) to lose their critical role in the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The European Medicines Agency provided draft guidance documents focused on the quality of oral modified release products and transdermal delivery patches last week. The EMA anticipates a response by March 2013. The guidelines for patches are fixed toward developers...
The FDA released two new documents aimed to clarify the process for clinical trial approval and establishing earlier clinical trial studies during device development. The FDA is currently searching for a small number of companies to in the pilot program. Jeffery...
Health and Human Services announced in July a proposal to improve rules protecting human research. The proposed changes can be found in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects...
