FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products
Wednesday, December 12, 2012
Posted by: Natalia Gromov
The
Food and Drug Administration (FDA) has announced a 1-day public hearing, "FDA Actions Related to Nicotine
Replacement Therapies and Smoking-Cessation Products; Report to Congress on
Innovative Products and Treatments for Tobacco Dependence,” on December 17,
2012.
FDA is interested in obtaining input on certain questions related to the
implementation of section 918 of the Food, Drug, and Cosmetics Act, a provision
that was added by the Family Smoking Prevention and Tobacco Control Act of
2009.
Topics on which input is sought include applicable approval mechanisms and
additional indications for nicotine replacement therapies (NRTs), and the
regulation and development of innovative products and treatments for tobacco
dependence.
FDA is seeking input from interested stakeholders, including manufacturers,
industry and professional organizations, the public health community,
individuals affected by tobacco dependence, researchers, health care
professionals, and the public. Attendance is free and will be on a
first-come, first-served basis. Individuals who wish to present at the public
hearing must register by December
6, 2012, and provide complete contact information, including
name, title, affiliation, address, email, and phone number to: Section918PublicMeeting@fda.hhs.gov
.
Please find additional meeting details in the FederalRegister notice: http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-1148-0001
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