Originally posted by absurd99
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( http://www.fda.gov/downloads/Advisor.../UCM224762.pdf )
The assessment of an application for approval by FDA is performed by an interdisciplinary
team of agency subject-matter experts drawn from across the Center. In general, these teams
include molecular biologists, animal scientists, veterinarians, toxicologists, chemists,
statisticians, risk assessors, and other specialists, as required by the technical nature of each
component of the hierarchical review process. In general, this interdisciplinary team is
assembled as sponsors begin their interactions with the agency. Depending on the nature of
the submission, in-depth reviewers (at least two) are assigned to each submission, each of
whom prepares an initial individual evaluation of the data and information. For example, the
components that address the characterization of the construct generally have molecular
biologists acting as in-depth reviewers, while the phenotypic characterizations could have
veterinarians, animal scientists, and statisticians as in-depth reviewers. The evaluations
performed by the in-depth reviewers are presented to the full team, which has had the
submission available for review; the larger group acts as a peer-review panel for the in-depth
reviewers’ evaluations. Following discussion, the in-depth reviewers prepare a written
review, which is again subjected to peer review by the entire group. Once concurrence is
reached, the entire team signs off on the review. Each step in the hierarchical review process
is carried out in the same manner.
team of agency subject-matter experts drawn from across the Center. In general, these teams
include molecular biologists, animal scientists, veterinarians, toxicologists, chemists,
statisticians, risk assessors, and other specialists, as required by the technical nature of each
component of the hierarchical review process. In general, this interdisciplinary team is
assembled as sponsors begin their interactions with the agency. Depending on the nature of
the submission, in-depth reviewers (at least two) are assigned to each submission, each of
whom prepares an initial individual evaluation of the data and information. For example, the
components that address the characterization of the construct generally have molecular
biologists acting as in-depth reviewers, while the phenotypic characterizations could have
veterinarians, animal scientists, and statisticians as in-depth reviewers. The evaluations
performed by the in-depth reviewers are presented to the full team, which has had the
submission available for review; the larger group acts as a peer-review panel for the in-depth
reviewers’ evaluations. Following discussion, the in-depth reviewers prepare a written
review, which is again subjected to peer review by the entire group. Once concurrence is
reached, the entire team signs off on the review. Each step in the hierarchical review process
is carried out in the same manner.
of course, it seems to me that if it was advantageous to grow that fast... then the forces of nature would have selected genes like that, no? it seems like a trait which shuts off growing in certain conditions would have been evolved deliberately as a survival trait. disable that and the chances of survival would decrease...?
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