Marketing Applications

Responding to information requests (IRs) from FDA during review of a marketing application can be stressful. How do you survive the rollercoaster of requests? We have outlined useful tips and best practices for managing responses to IRs during FDA review of your marketing application.

FDA’s Benefit-Risk Framework is the presentation for communicating the assessment of the benefits and risks based on the therapeutic context, available evidence and uncertainties for the product in development.

Are you developing a new product and wondering whether it falls under the classification of a drug or a medical device?  While some products clearly fit in one classification or the other, with advancements in science and technology, products can have features that blur the lines between drug and device.  Navigating the regulatory landscape is often a complex but critical aspect of bringing your innovation to market.  In this series, we will explore the regulatory mechanisms available to help you distinguish a medical device from a drug product and to utilize FDA’s regulatory pathways specific to each, particularly in early development.

The Prescription Drug and User Fee Act (PDUFA), first enacted in 1992, was put in place to ensure timely FDA approval or licensure decisions of New Drug Applications (NDAs) and Biologics License Applications (BLAs). To streamline this decision-making process, the FDA developed a structured benefit-risk assessment framework designed to highlight uncertainties about a drug’s safety and efficacy in the indicated population and where new findings, as they become available in the post-market setting, can be incorporated into the framework.