Getting Your Investigational Drug Regulatory Ready

From the moment an application for an investigational new drug is submitted, there is pressure from regulators to provide a plan detailing drug safety, quality, and efficacy. The drug approval process is rigorous, but for good reason. Patients are anxiously awaiting new treatment options, and their protection is of utmost importance.

Navigating regulatory requirements can be overwhelming and time consuming. Explore some basic information and useful strategies to help you facilitate efficient regulatory review and drug approval.