On October 27, the FDA is holding a public hearing on Long Term Use of NRTs. I have sent off a request to speak. If I am not selected, I will be able to submit written testimony.
I would like to hear from NRT users in this forum. What points do you think should be made regarding whether the FDA should leave the NRT directions as-is (use the product for about 12 weeks to wean down & off nicotine) or to approve NRT products for long-term use?
They might be thinking of just allowing a longer time-frame for the weaning, or they might actually be considering the concept of nicotine maintenance via pharmaceutical products.
The public hearing comes inside of a 2-day workshop on the topic.
I would like to hear from NRT users in this forum. What points do you think should be made regarding whether the FDA should leave the NRT directions as-is (use the product for about 12 weeks to wean down & off nicotine) or to approve NRT products for long-term use?
They might be thinking of just allowing a longer time-frame for the weaning, or they might actually be considering the concept of nicotine maintenance via pharmaceutical products.
The public hearing comes inside of a 2-day workshop on the topic.
Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products; Public Workshop
DATE: October 26-27, 2010
TIME: 8:30 a.m. to 5:00 p.m.
LOCATION: Radisson Hotel, Reagan National Airport, 2020 Jefferson Davis Highway, Arlington, VA 22202
CONTACTS: Mary C. Gross, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6178, Silver Spring, MD 20993–0002, 301–796–3519, email: mary.gross@fda.hhs.gov
FDA, Center for Drug Evaluation and Research (CDER) is announcing a scientific workshop that will focus on the risks and benefits associated with the long-term use of nicotine replacement therapy (NRT) products
Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products; Public Workshop
http://edocket.access.gpo.gov/2010/pdf/2010-21894.pdf