Food and Drug Administration Small Business and Industry Assistance Regulatory Education for Industry Spring Conference; Public Conference

摘要

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), together with the Center for Devices and Radiological Health (CDRH), is sponsoring a 2-day public conference entitled "FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Spring Conference." The goal of this public conference is to provide direct, relevant, and helpful information on the key aspects of drug and medical device regulations in order to increase regulatory certainty and predictability for pharmaceutical and/or medical device industry. Our primary audience is that of small manufacturers of drug and/or medical devices who want to learn about how FDA approaches the regulation of drugs and medical devices and for whom increased certainty and predictability will help to decrease the regulatory burdens that can be associated with a lack of understanding of, or familiarity with, FDA's drug and medical device regulations. However, anyone involved in the pharmaceutical and/or medical device industry may attend.