tag:blogger.com,1999:blog-2670285911995096389.post4874288319216624763..comments2024-03-26T00:00:44.845-04:00Comments on Tobacco Truth: Regulatory Purgatory: Tobacco Harm Reduction at RiskBrad Roduhttp://www.blogger.com/profile/02780515717969719311noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-2670285911995096389.post-53305776595866938892012-05-10T15:51:59.781-04:002012-05-10T15:51:59.781-04:00At least with a drug approval, the requirements to...At least with a drug approval, the requirements to demonstrate safety and efficacy are reasonably well understood -- both by private industry and the Agency itself.... In contrast, the guidance for modified risk is entirely unclear, raising the obvious, material risk than the applicant will be subject to ever moving goal posts (goal posts which, even if liberally administered are out of reach to all but perhaps the two largest players). It is unfortunate, and congressional review of the implementation of modified risk by the CTP is in order.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-2670285911995096389.post-34795671635715193252012-05-06T08:34:58.342-04:002012-05-06T08:34:58.342-04:00As much as it is wrapped in the language of compas...As much as it is wrapped in the language of compassion and concern for peoples health and pseudo-scientific research objectives, it is in fact just another govt.-employment-program/war/waste-of-tax-dollars.Anonymousnoreply@blogger.com