Bradley Merrill Thompson Quoted in Article “FDA Issues Long-Awaited Combo Product GMPs, Industry Seeks Further Guidance”

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "FDA Issues Long-Awaited Combo Product GMPs, Industry Seeks Further Guidance."

Following is an excerpt:

In about six months combination product manufacturers will have to start complying with good manufacturing practices that were finalized Friday after several years of rulemaking procedures and include a few key changes from FDA's earlier proposal. ?...

Bradley Merrill Thompson, general counsel to the Combination Products Coalition, noted that the final rule says that design controls could be applied broadly to all constituents or components of the combination product, which he says suggests that drugs and devices may not retain their regulatory status after being combined as was earlier the case. Another key change, he said, is the rule's treatment of syringes as devices, which will affect companies making pre-filled syringes. ?...

Thompson said the 180-day time frame gives companies little time to sort out these issues, noting that guidance is needed to help companies comply.

"It's going to be terribly important that FDA come out with the implementing guidance very quickly so that companies can start modifying their quality systems as necessary," he said. "For many companies, obviously, they'd rather simply do it once and get it right, and having a guidance document will be necessary to do that."