GPhA, IPEC Push FDA to Form Working Groups With Industry

As the FDA makes plans for its GDUFA-mandated fiscal 2017 Regulatory Science Plan, industry trade groups are pushing the agency to spend more time communicating its intentions.

Speaking at an FDA public meeting on last week, representatives of two trade groups — GPhA’s Senior Vice President for Sciences and Regulatory Affairs David Gaugh and David Schoneker, vice chair for scientific and regulatory affairs of the International Pharmaceutical Excipient Councils — stressed the importance of forming FDA-industry working groups to identify regulatory science priorities.

“GPhA and other stakeholders dialogue with the FDA to explore how best to broaden industry’s input into the development process,” Gaugh said. “But today, no action plans we have presented have been taken up. One public hearing is not considered to be enough.”