CDER Small Business and Industry Assistance Resources
Do you have questions for FDA on drug development or regulations?
CDER Small Business and Industry Assistance (SBIA) is often the first stop for the pharmaceutical industry in trying to contact the Agency. Their goal is to help small pharmaceutical business and industry navigate the wealth of information that FDA offers, and to provide assistance in understanding the regulation of human drug products. Providing support to industry through education and resources is essential to advancing innovation and protecting public health.
The Center for Drug Evaluation and Research's Small Business and Industry Assistance office has just launched a new web-based learning tutorial: Best Practices for Communication Between FDA and IND Sponsors During Drug Development. The one-hour course describes best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development.
FDA hosted a webinar to share information and answer questions about the final guidance document, Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types. The purpose of this document is to provide recommendations to industry about the regulation of accessories to medical devices. The guidance provides clarification on the definition of a medical device accessory. It recommends classifying accessories according to their level of risk when used as intended with a parent device to ensure their safety and effectiveness while reducing burden to manufacturers. It also encourages manufacturers to use the de novo process to request risk-based classification for new accessories when appropriate. A transcript, recording, and the slide presentation are available at: http://www.fda.gov/CDRHWebinar.
Watch NEW video to learn more about CDER SBIA and how they can help you!