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This comment from Moderator.1
I. Definitions
The term “test article” is found in the FDA regulations on Protection of Human Subjects (21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products. The JHM IRB will review research involving the use of a drug other than the use of a marketed drug in the course of medical practice.
II. What kind of review process will the IRB conduct if the intent of the research in humans is to develop information about safety and efficacy of drugs or devices for submission to, or inspection by, the FDA?
1. Type of IRB Review
If a test article does not meet the criteria for an expedited review procedure, the study must be reviewed at a convened IRB meeting.
2. Drugs, Botanicals, Biologicals, or Other Substances
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This comment from Moderator.2
I. Definition
The term “test article” is found in the FDA regulations on Protection of Human Subjects (21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products. The JHM IRB will review research involving the use of a drug other than the use of a marketed drug in the course of medical practice.
II. What kind of review process will the IRB conduct if the intent of the research in humans is to develop information about safety and efficacy of drugs or devices for submission to, or inspection by, the FDA?
1. Type of IRB Review
If a test article does not meet the criteria for an expedited review procedure, the study must be reviewed at a convened IRB meeting.
2. Drugs, Botanicals, Biologicals, or Other Substances
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This comment from Moderator.3
I. Definition
The term “test article” is found in the FDA regulations on Protection of Human Subjects (21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products. The JHM IRB will review research involving the use of a drug other than the use of a marketed drug in the course of medical practice.
II. What kind of review process will the IRB conduct if the intent of the research in humans is to develop information about safety and efficacy of drugs or devices for submission to, or inspection by, the FDA?
1. Type of IRB Review
If a test article does not meet the criteria for an expedited review procedure, the study must be reviewed at a convened IRB meeting.
2. Drugs, Botanicals, Biologicals, or Other SubstancesI. Definition
The term “test article” is found in the FDA regulations on Protection of Human Subjects (21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products. The JHM IRB will review research involving the use of a drug other than the use of a marketed drug in the course of medical practice.
II. What kind of review process will the IRB conduct if the intent of the research in humans is to develop information about safety and efficacy of drugs or devices for submission to, or inspection by, the FDA?
1. Type of IRB Review
If a test article does not meet the criteria for an expedited review procedure, the study must be reviewed at a convened IRB meeting.
2. Drugs, Botanicals, Biologicals, or Other Substances
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This comment from Moderator.4
I. Definition
The term “test article” is found in the FDA regulations on Protection of Human Subjects (21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products. The JHM IRB will review research involving the use of a drug other than the use of a marketed drug in the course of medical practice.
II. What kind of review process will the IRB conduct if the intent of the research in humans is to develop information about safety and efficacy of drugs or devices for submission to, or inspection by, the FDA?
1. Type of IRB Review
If a test article does not meet the criteria for an expedited review procedure, the study must be reviewed at a convened IRB meeting.
2. Drugs, Botanicals, Biologicals, or Other SubstancesI. Definition
The term “test article” is found in the FDA regulations on Protection of Human Subjects (21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products. The JHM IRB will review research involving the use of a drug other than the use of a marketed drug in the course of medical practice.
II. What kind of review process will the IRB conduct if the intent of the research in humans is to develop information about safety and efficacy of drugs or devices for submission to, or inspection by, the FDA?
1. Type of IRB Review
If a test article does not meet the criteria for an expedited review procedure, the study must be reviewed at a convened IRB meeting.
2. Drugs, Botanicals, Biologicals, or Other Substances
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This comment from Moderator.5
I. Definition
The term “test article” is found in the FDA regulations on Protection of Human Subjects (21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products. The JHM IRB will review research involving the use of a drug other than the use of a marketed drug in the course of medical practice.
II. What kind of review process will the IRB conduct if the intent of the research in humans is to develop information about safety and efficacy of drugs or devices for submission to, or inspection by, the FDA?
1. Type of IRB Review
If a test article does not meet the criteria for an expedited review procedure, the study must be reviewed at a convened IRB meeting.
2. Drugs, Botanicals, Biologicals, or Other Substances
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I. Definition
The term “test article” is found in the FDA regulations on Protection of Human Subjects (21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products. The JHM IRB will review research involving the use of a drug other than the use of a marketed drug in the course of medical practice.
II. What kind of review process will the IRB conduct if the intent of the research in humans is to develop information about safety and efficacy of drugs or devices for submission to, or inspection by, the FDA?
1. Type of IRB Review
If a test article does not meet the criteria for an expedited review procedure, the study must be reviewed at a convened IRB meeting.
2. Drugs, Botanicals, Biologicals, or Other Substances
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I. Definition
The term “test article” is found in the FDA regulations on Protection of Human Subjects (21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products. The JHM IRB will review research involving the use of a drug other than the use of a marketed drug in the course of medical practice.
II. What kind of review process will the IRB conduct if the intent of the research in humans is to develop information about safety and efficacy of drugs or devices for submission to, or inspection by, the FDA?
1. Type of IRB Review
If a test article does not meet the criteria for an expedited review procedure, the study must be reviewed at a convened IRB meeting.
2. Drugs, Botanicals, Biologicals, or Other Substances
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I. Definition
The term “test article” is found in the FDA regulations on Protection of Human Subjects (21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products. The JHM IRB will review research involving the use of a drug other than the use of a marketed drug in the course of medical practice.
II. What kind of review process will the IRB conduct if the intent of the research in humans is to develop information about safety and efficacy of drugs or devices for submission to, or inspection by, the FDA?
1. Type of IRB Review
If a test article does not meet the criteria for an expedited review procedure, the study must be reviewed at a convened IRB meeting.
2. Drugs, Botanicals, Biologicals, or Other Substances
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