Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted in an article about the Food and Drug Administration’s proposed rule intended to give makers of combination products a transparent and streamlined regulatory framework for demonstrating compliance with manufacturing standards.
The article, “FDA Proposes Rule on Industry Practices for Making Combination Products,” stated that companies would have two options for demonstrating compliance with the current good manufacturing practice (cGMP) requirements applicable to each of the constituent parts when drugs, devices, and biological products are combined to create a combination product, under the FDA proposed rule.
Thompson said the first option, demonstrating compliance for all the individual parts in the combination product, “is not attractive” to industry. He said the general idea behind the second option is to have a company adopt one compliance system as a baseline, and then graft onto it any additional procedures.
The proposed rule, said Thompson, is similar to a draft guidance on combination products FDA issued in 2004, but provides a “much clearer explanation” of what FDA is looking for. He said it also allows for industry and FDA to have a much-needed dialogue for the first time in five years about combination product compliance.