FDA provides guidance which is not a requirement.
Post# of 154776
(Total Views: 781)
Posted On: 12/15/2021 12:39:02 PM
FDA provides guidance which is not a requirement. You can read all about it to make your own determination since you disagree with what I am telling you from my experience:
https://www.fda.gov/media/75398/download
For instance:
FDA does not chose DSMC members. It gives guidance about data and safety monitoring.
To say that FDA screwed CYDY shareholders by sabotaging the DSMC is a pretty wild conspiracy that simply isn't true.
https://www.fda.gov/media/75398/download
For instance:
Quote:
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
Quote:
All clinical trials require safety monitoring, but not all trials require monitoring by a formal committee that may be external to the trial organizers, sponsors, and investigators.
Quote:
The sponsor and/or trial steering committee generally appoint members of a DMC. Factors to consider in the selection of individuals to serve on a DMC typically include relevant expertise, experience in clinical trials and in serving on other DMCs, and absence of serious conflicts of interest as discussed below. The objectives and design of the trial and the scope of the responsibilities given to the DMC determine the types of expertise needed for a particular DMC.
Most DMCs are composed of clinicians with expertise in relevant clinical specialties and at least one biostatistician knowledgeable about statistical methods for clinical trials and sequential analysis of trial data. For trials with unusually high risks or with broad public health implications, the DMC may include a medical ethicist knowledgeable about the design, conduct, and interpretation of clinical trials. Prior DMC experience is important when considering the committee as a whole; it is highly desirable that at least some members have prior DMC service. Prior DMC experience is particularly important for the statistical DMC member if there is only one statistician serving on the DMC.
FDA does not chose DSMC members. It gives guidance about data and safety monitoring.
To say that FDA screwed CYDY shareholders by sabotaging the DSMC is a pretty wild conspiracy that simply isn't true.
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