CDER reiterates expectation for multiple trials to demonstrate efficacy for an IND different from approved products, such as route of administration, for smoking cessation or reduction in risk of relapse. Agency offers access to expedited approval pathways by showing significant improvement in efficacy or safety over existing therapies or addressing unmet medical need.
The US Food and Drug Administration’s guidance on clinical trials for smoking cessation or related indications changed little from draft to final published after four years, two commissioners and a stalled novel OTC product proposal.
The guidance, released on 28 April, reiterates the Center for Drug Evaluation and Research expectations for multiple clinical trials...