Introduction

The pharmaceutical industry is of great importance to the economy, providing both tax revenues and jobs. Hence it, and the regulation of it, has become a political topic as well. Despite the political vitriol you may hear in the popular press, the FDA is a non-partisan, progressive, highly sophisticated agency, filled with domain experts across the spectrum of therapeutics development, and well beyond. When they say “no”, they’re vilified, and when they say “yes”, the developer is the hero. It’s a demanding and difficult role, and you should expect exceptional expertise.

What

The FDA is tasked with protecting human health broadly; their therapeutics regulatory role is only a small part of their remit. Understanding the Agency’s 9 organizational structure is necessary to begin to engage with the experts within.

When

Planning for regulatory can begin as soon as the product is conceptualized. Actively developing regulatory strategy and documentation typically begins as preclinical Proof of Concept is achieved. FDA has a number of mechanisms for communication and feedback. Understanding when to and how to use them will save time, money and energy.

Why

Without regulatory approval, your therapy cannot touch a patient, nor be sold in the market.

Learning Goals

FDA’s role in therapeutics development, standard and special (breakthrough, fast track, priority review, and accelerated approval) pathways, and other useful regulatory resources.