2017 - Best Practices in Clinical Pharmacology Gap Analysis

Submitting your New Drug Application (NDA) to the US Food and Drug Administration (FDA) is the ultimate test of a drug program. Are you confident that you’ll have robust answers to the 40 different questions that the agency will ask about your clinical pharmacology data package at the time of an NDA submission? If the thought gives you “pre-test jitters,” you might want to invest in a clinical pharmacology gap analysis– a tool that can help you evaluate and address any potential gaps in your program before the FDA does.