5 Adverse Events with New Chemical Entities, Generics, Excipients, Placebos, and Counterfeits Are some adverse events (AEs) created more equal than others? Are some AEs more important than others? Why…
31 The United States FDA’s Three Risk Guidances of 2005 In March 2005, the U.S. Food and Drug Administration (FDA) issued three guidances, which were years in the making, summarizing…
33 Product Quality Issues In the past several years, it has been realized that many other issues in addition to bad reactions to the active chemical entity in the product…
2 Clinical Trials, Clinical Research Organizations, Phases I–IV, and Investigator-Initiated Trials To obtain approval to market a new drug in the United States, Canada, the European Union, and most other…
23 The Qualified Person for Pharmacovigilance For companies with products sold in the European Union, Volume 9A requires that there be a “Qualified Person for Pharmacovigilance” (QPPV or QP). This…
54 Real-World Issues: Nomifensine Nomifensine (Merital) was first used as an antidepressant in Germany in 1976, in the United Kingdom in 1977, and in the United States in 1985. From…
27 The Uppsala Monitoring Centre The Uppsala Monitoring Centre (UMC), in addition to maintaining three databases (Vigibase, WHO Drug Dictionary Enhanced, and WHO-ART; see Chapter 14) also provides many services…
53 Real-World Issues: Fen-Phen What is now called the “fen-phen” issue refers to the combination of fenfluramine and phentermine. Both products had long been approved (in 1973 and 1959, respectively)…
32 Data Management Committees and IRBs/Ethics Committees Data Management Committees Over the years, in addition to Investigational Review Boards (IRBs), the concept of a separate and additional independent group to…
26 Australia Therapeutic Goods Administration (TGA) The Therapeutic Goods Administration (TGA), located near Canberra, is charged with drug and device safety for Australia. AE Reporting The reporting of adverse…
