US Smoking Cessation Clinical Trials Guidance ‘Does Not Envision’ Flexibility On Indications
FDA final guidance maintains limit on secondary endpoints allowed for trials, which could dissuade some investment in research for NDAs for smoking cessation products. NRT developers could find more room for novel product proposals from changes to some phrasing.
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US FDA Calls For Clinical Trial Diversity Plan ‘As Soon As Practicable’ In Product Development
Draft guidance outlines Race and Diversity Plan that would reify some of FDA’s efforts to increase racial and ethnic diversity in clinical trials with a mechanism that is applicable from IND through approval.
Emotional Backdrop Smolders As FDA Reviews Smoking Cessation Category
FDA asks for comments including evidence needed to show safety and efficacy for novel nicotine replacement therapies, but speakers at recent hearing highlight the public's psychological toll from tobacco-related deaths and the emotional connection smokers have with tobacco and nicotine.
US Hemp Industry Group Rings Alarm With Congress About FDA’s Safety Conclusions
US Hemp Roundtable general counsel cautions congressional leaders about “agency’s misguided use of incomplete safety data as the basis for its continued refusal to regulate CBD as a dietary supplement or food additive.”