Exact(4)
In the case of the extended-release dosage forms, the potential need for the conduct of one or more pivotal bioavailability/bioequivalence (BA/BE) studies was recognized and, as a result, included a recommended decision tree to determine when a BE study would be needed to prove equivalence.
The officer who presides over the rulemaking proceeding shall make a recommended decision based upon the findings and conclusions of such officer as to all relevant and material evidence, except that such recommended decision may be made by another officer if the officer who presided over the proceeding is no longer available to the Commission.
Thirdly, in taking a recommended decision analytical approach, 15 we refined the structure of a previous model by allowing prosthesis failure to occur in the first year after the primary hip replacement or after revision surgery.
Decision analytic modeling can synthesize evidence based knowledge to estimate the outcomes of decisions and provide a recommended decision but has not been used before to inform the content of AD.
Similar(56)
CEACs are a recommended decision-making approach to dealing with uncertainty around the estimates of expected costs and effects and uncertainty regarding the maximum cost-effectiveness ratio a decision-maker would consider acceptable [ 32, 33].
In decision support enabled mode (DS+), recommended decision options are highlighted by green ticks; non-recommended options are marked by red crosses.
§ 900.12 Administrator's recommended decision.
Recommended Decision at 8, J.A. B-79.
§ 622.12 Proposed findings and conclusions; recommended decision.
Recommended Decision at 9, J.A. B-80.
Recommended Decision at 7-8, J.A. B-78 to B-79.
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