Review:
Fda Regulations On Clinical Trials
overall review score: 4.5
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score is between 0 and 5
FDA regulations on clinical trials refer to the guidelines and requirements set by the Food and Drug Administration for conducting clinical trials in the United States.
Key Features
- Ensures safety and efficacy of investigational drugs
- Protects human subjects participating in trials
- Requires submission of detailed protocols and informed consent documents
- Mandates reporting of adverse events and study results
- Guides the process for drug approval
Pros
- Ensures ethical treatment of participants
- Provides clear guidelines for trial conduct
- Facilitates drug approval process
Cons
- Can be time-consuming and costly for researchers
- Stringent requirements may limit innovation