Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval Process
Executive Summary
The “Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFL isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.
You may also be interested in...
A New OTC Switch Pathway In US At Last: Acronym Isn’t The Only Thing That’s Changed
FDA proposes a novel pathway to permit OTC drugs to be marketed with additional controls to assure appropriate use, more than a decade after floating the idea. The pathway has a new name (“ACNU” not “NSURE”) and very different commercial dynamics.
A New OTC Pathway At Last: The Acronym Isn’t The Only Thing That’s Changed
The US FDA is proposing a novel pathway to permit OTC drugs to be marketed with some additional controls to assure appropriate use, more than a decade after floating the idea. The pathway has a new name (“ACNU” not “NSURE”) and very different commercial dynamics.
Before Asking FDA For Novel OTC Switch, Be Sure DFL Alone 'Can't Get There'
"You need to demonstrate to the best of your ability that you can't get there with just the Drug Facts label," says ONDP Director Theresa Michele during presentation on the FDA office' work over the past year at Consumer Healthcare Products Association's annual regulations and science conference.