Bradley Merrill Thompson, a Member of the Health Care and Life Sciences practice in the Washington, DC office, was quoted in an article titled “Combination Products Office Finalizing Manufacturing, Adverse Event Rules.”
According to the article, FDA says final rules on good manufacturing practices and adverse event reporting for combination products could be out as early as this fall.
“Every week that passes, more companies are building plants and making financial investments in their production systems that may be out of date once that rule comes out,” said Thompson.
Thompson said his group is gathering “nitty gritty implementation questions” from its members to send to FDA.
This is a key issue for manufacturers because “a lot of companies are on third, fourth, fifth-generation products,” Thompson said. “There’s a lot of complexity around what the submission obligations are when you modify, for example, just the device component of a drug-device combination.”
“There is a lot of information which, if it were put on the website, would be a fairly modest hassle for the agency but would really help companies operate in this space,” Thompson said.
In the absence of abundant guidance on combination products, he noted, when companies can at least see how decisions are being made, “they can infer what the rules are.”