Drugmakers Question OND’s Combination Product Reviews

In a comment to the Office of New Drugs, Janssen flagged problems it faced during OND reviews of combination products.

“Based on our experience with combination product submissions, in some cases it appears the industry and the agency may be taking different approaches to risk management,” said Liza O’Dowd, vice president at Janssen Research and Development.

Janssen made the observation in a letter filed in response to a request for comments on how OND could promote effective drug development programs.