Bradley Merrill Thompson Quoted in “Manufacturers Seek More Clarity On GMP Obligations for Combo Products”The Gray Sheet May 11, 2015
Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted inPharma & MedTech Business Intelligence’s The Gray Sheet, in “Manufacturers Seek More Clarity On GMP Obligations for Combo Products,” by Sue Darcey. (Read the full version — subscription required.)
Following is an excerpt:
“Pharmaceutical and biotechnology companies have been manufacturing safe and effective prefilled syringes and other simple combination products … for several decades without formal design controls,” stated Bradley Thompson, an attorney with Epstein Becker & Green P.C., on behalf of CPC. “Although benefits may flow from adopting design controls for these products … these new controls should be: narrowly tailored to focus on the combination only, leverage existing, highly regulated, drug cGMP systems … and leverage existing postmarket surveillance system data and other available information,” he wrote.