Development of the FDA Tobacco Credibility Scale (FDA-TCS)

The FDA, e-cigarettes, and the demise of combusted tobacco.

n engl j med 371;16 nejm.org october 16, 2014 1469 the devices, deeming them to be subject to regulation as tobacco products.1 The term “e-cigarette” (which the regulations do not define) generally refers to a variety of battery-powered inhaler devices that deliver aerosolized, refined nicotine in a humectant. In 2014, Americans will spend about $2.2 billion on e-cigarettes — numbers that excee...

The FDA reboot of antibiotic development.

In May 2012, a number of us listened spellbound as Janet Woodcock of the FDA announced at a meeting at the Brookings Institution that the agency would “reboot” their entire approach to antibiotic development (J. Woodcock, presented at an Expert Workshop on Facilitating Antibacterial Drug Development, 9 May 2012). She recognized that there is a public health crisis of antibiotic resistance that ...

The need for FDA regulation of tobacco products.

FDA Unveils Product Development Priorities

Priorities H ealth and Human Services (HHS) Secretary Mike Leavitt and the Food and Drug Administration (FDA) released on March 16 an initial list of priority research projects aimed at advancing innovation in medical products. The Critical Path Opportunities List, part of the FDA Critical Path Initiative, outlines 76 initial projects to bridge the gap between the quick pace of new biomedical d...

The FDA "Deeming Rule" and Tobacco Regulatory Research.

In May 2016, the Food and Drug Administration extended its tobacco regulatory authorities to other products meeting the definition of a tobacco product (Deeming Rule). This authority now includes, but is not limited to, electronic nicotine delivery systems (ENDS), such as electronic cigarettes, as well as all cigars, pipes, and hookahs (waterpipes). The FDA's Center for Tobacco Products has bee...