INTRODUCTION This guidance provides recommendations for biological product, drug, and device firms on FDA’s current thinking concerning the testing recommendations and acceptance criteria in the United States Pharmacopeia (USP) Chapter Bacterial Endotoxins Test, USP Chapter Transfusion and Infusion Assemblies and Similar Medical Devices161>,and the Association for the Advancement of Medical Instrumentation (AAMI) ST72:2002/R2010, Bacterial Endotoxins—Test ..
Category : Clinical
What is the work of clinical data management? Overall, clinical data managers are responsible for collecting data from a variety of medical research projects, such as clinical and pharmaceutical trials. They work collaboratively to make sure data is collected, managed and reported clearly, accurately and securely. Role of the clinical data manager in a clinical ..
FDA uses Compliance Program Guidance Manuals (CPGM) to direct its field personnel on the conduct of inspectional and investigational activities. The CPGM’s described below form the basis of FDA’s Bioresearch Monitoring Program. The purpose of each program is to ensure the protection of research subjects and the integrity of data submitted to the agency in ..