Introduction to Regulatory Statistics: Principles for Drug Approval at FDA

• Activity Number: 2
• Type: Invited
• Date/Time: Sunday, July 29, 2012 : 2:00 PM to 3:50 PM
• Sponsor: SPAIG Committee
• Author(s): Peter (Tony) Lachenbruch*+
• Companies: Oregon State University
• Keywords: Drug approval

Abstract

Medical research involves discovery of basic principles while drug development involves the application of these principles to a product. Exploratory analyses of a drug development clinical trial data set are important, but should not be used in a licensing application as they often involve discovered endpoints or subgroups. The drug regulation process is not like a final exam in which 'no help' is allowed; it is a process in which the study plans are evolved and iterated to get a better product to market (or to determine that it shouldn't be on the market). Drugs are regulated by agencies. The FDA is the focus of this talk as I'm more familiar with procedures there. FDA has 3 main human product centers : Center for Biologics (CBER), Center for Devices and Radiologic Health (CDRH), Center for Drugs (CDER). The three centers have slightly different approval procedures. CDRH has the option of 'clearing' a device that is substantially similar to an already approved device. It is vitally important that sponsors/statisticians understand the requirements of the FDA. The FDA publishes guidances to help clarify these issues.