Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted in The Gray Sheet on the FDA’s proposed adverse event reporting requirements for combination products.
The article, “Combo Product Firms Want Simpler Adverse Event Reporting Structure,” stated that companies believe the rules should be rewritten to simplify the way events are reported when multiple manufacturers are involved.
Combination product makers generally have said that the FDA’s “streamlined” approach, outlined in the agency’s proposed rule, is an improvement.
Before, “there was quite a bit of variability,” said Thompson. “Some were clearly over-reporting, some were perhaps underreporting, and some were hitting it about right.”
But there are still questions that require attention in the final rule, he added.