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All clinical trials require monitoring at multiple levels. The Data Safety Monitoring Board (DSMB) is required for certain types of federally funded clinical trials and strongly recommended for others. The DSMBs operate similarly to the Institutional Review Board (IRB), but is not a substitute for the IRB. DSMBs periodically review unblinded data (interventions given to study subjects are known) including adverse events and other safety concerns once a study has been initiated, whereas IRBs review studies prior to and throughout the course of the study. IRBs do not typically unblinded data.
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The current body of laws and regulations, clinical standards, policies and procedures, and ethical principles governing the conduct of research involving human subjects. All levels of oversight (international, federal, state, and local agencies; institutional policies; etc) should be considered when defining the GCP for a specific study. The term is commonly associated with clinical trials.
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Implant means a device that is placed into a surgically or naturally formed cavity of the human body. A device
is considered to be an implant for the purpose of 21 CFR 860 only if it is intended
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The Food and Drug Administration is authorized to limit competition for certain manufacturers of pharmaceuticals and biological agents (there is no authorization for market exclusivity for devices). During the period of 'market exclusivity', FDA will not approve competing products (e.g., generic drugs) for marketing. Market exclusivity is independent of any patent rights and can extend beyond the expiration of patent protections. Possible reasons for granting market exclusivity include:
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Investigators are required to maintain a detailed case history of clinical trial activities for compliance, monitoring and audit purposes. The Note to File (NTF) is a method of documenting events in a
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Also called '510(k) approval'. Manufacturers are required to notify the Food and Drug Administration (FDA) at least 90 days prior to marketing a new medical device. This provides FDA with time to properly classify the risk class. Manufacturers that can demonstrate that thier device is 'substantially equivalent' to a device that was legally marketed prior to May 28, 1976 (date of enactment of the Medical Device Amendments) or is not subject to 'Premarket Approval' standards. Premarket Approval is the most stringent standards to establish safety and effectiveness. FDA maintains a database of devices approved under the Premarket Norification/510(k) method (
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