Attorneys: Cures Language Could Give Exclusivity To Old Drugs

Language in 21st Century Cures could allow combination products that rely on previously approved drugs to go through the 505(b)(2) pathway, which could grant these drugs new exclusivity, attorney sources tell IHP . However, a combination products attorney and a congressional staffer close to the negotiations maintained that FDA already has the authority to grant exclusivity to a combo product submitted under a 505(b)(2) and that the language was added to ensure combination products that go through a device pathway...