The Regulatory Education for Industry (REdI) Program was established in 2012 as a FDA-led forum that brings together the regulatory educators from FDA's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH). Program is free.
To provide direct, relevant, and helpful information on the key aspects of drug and device regulations.
Small manufacturers of drug and/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices.
Program Series and Format:
- Starting in 2018, REdI is held annually.
- REdI is held at a different location in the United States. We try to go to areas of the country with a high concentration of new businesses.
- The program is two days: Day 1 address premarket topics. Day 2 address postmarket topics.
- REdI features a plenary session that combines the themes of drug and device regulatory policy. Prior topics have featured: Combination Products, Companion Diagnostics, Products for Rare Diseases and Pediatrics, and Human Factors.
- The program is delivered in a hybrid format: you may attend in person or remotely through Adobe Connect.