The road to drug approval: Challenges and strategies

Ask the Experts: The Long Road to FDA Approvals - GO2 for Lung Cancer

Author: Matthew Reiss, MSE, PhD, Manager, Precision Medicine & Navigation, GO2 for Lung Cancer Question: Why does it take so long for the FDA to approve new drugs?   Answer: Whenever a new cancer drug is created, it raises the question: Could this potentially be the next big advancement in treatment? While the process of going from discovery to an approved cancer therapy is designed to ensure safety and efficacy before the drug reaches people, t…

The road to drug approval: Challenges and strategies

In the fifth episode of a six-part interview series on immunotherapy, Marc Voigt, CEO and Executive Director of Immutep (ASX:IMM), explains the complex and heavily regulated process of bringing a new drug to market. The journey from discovery to approval can take over 15 years, involving preclinical development, multiple phases of clinical trials, and stringent regulatory scrutiny. The FDA is particularly influential, given that the US accounts …