Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted on a proposed rule by the FDA on good manufacturing practices for combination products.
The article, “FDA Attempts To Define Good Manufacturing Practices For Combo Products,” stated that the proposal is FDA’s first attempt to craft manufacturing regulations specific to combination products.
“At a high level, I’m pleased that, number one, they’ve got it up, because that starts a dialogue process that we really haven’t had for the last several years,” Thompson.
Once the rule is finalized, FDA intends to issue a companion guidance on implementing the streamlined approach, which Thompson said is “welcome news.”
“The proposed rule is at such a high level, as proposed rules generally are, that it leaves a lot of questions to interpretation,” he said.