FDA Regulatory Gauntlet Isn’t Getting Any Easier, Just Ask These Companies

Several companies this week got stark reminders that the FDA’s regulatory gauntlet is difficult to navigate in terms of getting treatments approved. Though it received backing from the Pulmonary-Allergy Drugs Advisory Committee in May, the FDA on Tuesday rejected ARS Pharmaceuticals’ neffy as a nasal spray for allergic reactions—a reminder that the regulator doesn’t have to follow the advice of its advisory committees. ARS plans to file a Formal Dispute Resolution Request appealing the FDA’s Complete Response Letter (CRL).