The FDA is welcoming congressional efforts to create a distinct review path for drug-device combination products. “It is a problem,” Janet Woodcock, head of the agency’s drug center, said at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing last week. “We need more clarity. We need a different path.” She added that the agency is eager to work with lawmakers on devising that path. Her comments coincided with the FDA reopening a 2009 comment period on how it reviews combination products. And next month, HELP will consider including the Combination Product Regulatory Fairness Act, introduced last June, in its trimmed-down response to the 21st Century Cures Act, which was passed by the House last year. (See BioWorld Today, Jan. 21, 2016.)