Industry Pushes for More Leeway in Safety Assessments for INDs

Industry groups have taken aim at an FDA recommendation on creating committees for assessing safety for INDs, saying the agency should adopt a more flexible approach.

The comments came in response to a draft guidance that called for creating safety assessment committees and formalized surveillance plans to watch for serious adverse events in clinical trials to decide when safety data should be unblinded.

In the draft document unveiled in December — which garnered comments from 14 different stakeholders — the FDA defined a safety assessment committee as a group of individuals who would review information in a development program and make a recommendation on whether the safety information must be reported in an IND safety report.

However, a number of industry organizations — including the Biotechnology Innovation Organization — have expressed concerns, adding that the agency should allow for more flexibility in how safety assessments for IND safety reporting are performed. This would allow companies to use their resources efficiently.