Attorneys: Cures Combo Product Language Could Give Exclusivity To Previously Approved Drugs

Language in the House-passed 21 st Century Cures bill 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...