Regulatory affairs plays a key role in the development and commercialization of medical products. In addition to guiding the strategic pathway, a product must be developed and manufactured to meet the safety, efficacy and quality requirements of FDA and other regulatory agencies. Early communication and interaction with FDA may save time and money during the development process.
First Contact with FDA: This 1-hour video is presented by the NHLBI Small Biz Hangout on how and when to approach the US FDA.
The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) website provides researchers with regulatory tools and resources to navigate the pathway for drugs, biologics and medical devices from discovery to clinical implementation
ReGARDD - Regulatory Guidance for Academic Research of Drugs and Devices
The Kentucky Network for Innovation & Commercialization (KYNETIC) has developed several videos providing an overview of regulatory approvals and commercialization.
Drug and biologics (CDER/CBER) approval process
Device Assistance and classification (CDRH)
Pre-IND (CDER, CBER) and INTERACT meetings are opportunities to request input from FDA on preclinical program and can decrease the cost and time of the development path.
This is a brief overview on the IND application process, interactions with the FDA, and investigator responsibilities during research conducted under an IND. This is provided by Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD).
These training modules provide an overview on IND Sponsor and Investigator Responsibilities.
These slides are provided by the Alabama Drug Discovery Alliance.
This is an overview from the FDA on how to design clinical trials.
This 2.5-hour workshop is provided by the UNC NC TraCS Institute.
University of California Center for Accelerated Innovation Resources