The rule provides a framework for potential licensure of medical products when
definitive efficacy studies that would involve exposing healthy human volunteers are unethical and field trials after accidental human exposure are not feasible.
Not exact matches
Whilst there are no RCT
studies available at this time to draw
definitive conclusions about the
efficacy of this process, many clinical reports exist to indicate that placenta encapsulation is helpful in the postpartum period in terms of increasing milk supply (acting as a galactagogue) and improving mood in the postpartum period.
Most
studies evaluating the
efficacy of AA are not
definitive; for the most part, they associate the duration of participation with success in quitting drinking but do not show that the program caused that outcome.
Sure wish there was a more
definitive study of iodine's
efficacy as a supplement.
According to Lise Alschuler, author of the
Definitive Guide To Cancer: An Integrative Approach to Prevention, Treatment, and Healing,
studies on flax lignans demonstrate safety and
efficacy in their use against breast cancer, «inhibiting the growth of human estrogen - dependent breast cancer cells in mice and strengthening the tumor - inhibitory effect of tamoxifen».
Definitive tests of these findings with respect to
efficacy require further well - designed
studies.