NRT Petition Calls On FDA To Greatly Expand Indications, Availability
This article was originally published in The Tan Sheet
Executive Summary
FDA's stated commitment to a public health approach to drug regulation will be put to the test by a petition to expand nicotine replacement therapy indications and availability
You may also be interested in...
Smoking Cessation Label Changes Could Lay Groundwork For Indications
FDA drops its requirement for labeling provisions for NRTs on duration of use and concomitant use of tobacco or other NRTs. Meanwhile, the agency rejects citizen petition requests for additional NRT indications, but says it is open to working with sponsors on developing those indications.
Smoking Cessation Label Changes Could Lay Groundwork For Indications
FDA drops its requirement for labeling provisions for NRTs on duration of use and concomitant use of tobacco or other NRTs. Meanwhile, the agency rejects citizen petition requests for additional NRT indications, but says it is open to working with sponsors on developing those indications.
FDA Asks For Road Map To Broader NRT Indications
While the agency appears to favor moving to a broad harm reduction framework for indications for NRTs, including lifting limits on recommended duration of use, there remains “a lot of devil in the details” of expanding indications.