Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Pharma & MedTech Business Intelligence’s The Gray Sheet, in “Combo Products Guidance Fills in Gaps on Drug-Delivery Device Regs,” by Sue Darcey. (Read the full version — subscription required.)
Following is an excerpt:
Bradley Thompson, an attorney who runs the industry Combination Products Coalition, says the document does a good job of clarifying compliance expectations for newly developed combination products.
"The 46 page guidance document addresses many of the questions that we have been asking," he said.
The primary gap in the document, he says, is a lack of clarify on how to address legacy products, such as prefilled syringes that have been on the market for decades and may not have been subject to device design controls or other GMP requirements described in the guidance. “To me it seems unnecessarily costly and in fact extraordinarily difficult, to try to go back somehow and apply design controls to those products,” Thompson remarked. …
Thompson said he will be closely reviewing that language with coalition members, which total about 50 companies with interests in combination products policy. It appears the guidance would subject legacy products to device design controls, albeit without the need for a specific development plan or design review meetings.
"I really wish they had talked more specifically about legacy products – those that are in some cases decades-old," he said.
