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 “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.
