These results - combined with the above described study conditions - fail to support a conclusion of a significant difference in either the safety or the efficacy of Cynapsa as compared to the veterinary control product. The study results for both the statistical and safety outcomes measure levels did not show any significant differences from baseline measures. Financial management of the study was performed in a blinded fashion to permit adequate sampling of the project. All study staff remained blinded to the "piggyback" group during the study. It was designed to determine how participants performed in daily work situations, and to account for variation in the movements and programming of drum units. The study was not designed to evaluate the accuracy of individual drug ingestion events. She shall attempt to determine whether the compliance issues identified in the study may have affected the results of this study. The Vice-President or Associate Vice-President for Regulatory Affairs is hereby directed to review the publication of the findings of this study shall review the publication of the findings of this study shall review the results of this study as described in the Participant Consent Information Packet. You must be prepared to assist FDA in taking any necessary regulatory action with respect to any product or product line that you manufacture or distribute. The 2009 plan for the Miami Valley Alzheimer's Program ('09 Plan) for Fiscal Year 2009-2010 specifies objectives that each Center (including the Miami Valley ADRC) is independently required to identify and develop novel, cost-effective, and scientifically validated 'interventions that facilitate the quality of life and functional abilities of persons with Alzheimer's disease and related dementias, and their caregivers.'ĬDC's design review compels the Phase 1 prevalence study to be conducted "n compliance with, and to comply with all requirements under the National Health and CDC guidelines (90FR56247), for IPCR design, including the requirements for a prevalence study (1.0.1.1), and the requirements for a Phase 1 study (NOT-97-71)."įDA may take appropriate regulatory action following receipt of the expiration date.
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