New date for industry nominations
This article was originally published in The Tan Sheet
Executive Summary
FDA pushes back the deadline for tobacco organizations to state their interest and submit nomination materials for three non-voting spots on the Tobacco Products Scientific Advisory Committee to Oct. 26, according to a Sept. 24 Federal Register 1notice amending an Aug. 26 notice that had set Oct. 15 as the deadline. The nine voting members on the advisory committee will include physicians, dentists, scientists or health care professionals practicing oncology, pulmonology, cardiology, toxicology, pharmacology, addiction or a relevant specialty; a government employee; and a public representative. Nominations for voting members are due by Oct. 13 (2"The Tan Sheet" Aug. 31, 2009, In Brief). ... FDA changes tobacco product information deadline: FDA asks tobacco product manufacturers to submit information about their products by Oct. 1, according to a Sept. 15 Federal Register 3notice. The agency had requested the information by Sept. 16 in a Sept. 1 Federal Register notice
You may also be interested in...
FDA establishes tobacco advisory committee
The agency describes in three Aug. 26 Federal Register notices its next steps in implementing the Family Smoking Prevention and Tobacco Control Act, including establishing the Tobacco Products Scientific Advisory Committee. The 1committee will consider the impact of menthol in cigarettes on the public health and other topics, and will report and offer recommendations to FDA within one year. The committee also must report within two years on the impact of dissolvable tobacco products on public health, including their use by children. In the second 2notice, FDA solicits nominations for nine voting members on the committee. Seven members will be physicians, dentists, scientists or health care professionals practicing oncology, pulmonology, cardiology, toxicology, pharmacology, addiction or a relevant specialty; one will be a government employee; and one will represent the public, the notice says. The third 3notice solicits nominations for three non-voting committee members from the tobacco industry and asks firms to participate in the committee selection process (4"The Tan Sheet" July 27, 2009). Nominations are due by Oct. 13
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.
Colorado Price Cap Plan For Enbrel Draws Amgen Lawsuit; Cosentyx, Stelara ‘Affordability’ Reviews Pending
However, the state's recently formed prescription drug affordability board found Gilead’s Genvoya and Vertex’s Trikafta to be affordable.