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The Role of the FDA in Clinical Trials |
In most cases, once a company decides to pursue a clinical trial, it must first submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for approval. The IND becomes effective 30 days after receipt by the FDA provided that the FDA does not require additional information. The application must be filed annually thereafter until the completion of the clinical trial. About 85% of all IND applications get approval to proceed to the clinical trial phase of testing.
The FDA plays a vital role in clinical trials. It is responsible for safeguarding public health by assuring that current and newer medical products are effective and safe to use, and that evaluations of potential new therapies are done properly. It also protects and promotes the health of every citizen and safeguards your rights as a participant in clinical trials. The FDAhas a series of regulations that clinical trials must abide by, including:
- What must be communicated to patients
- Consent requirements
- The data collection process
- Who can conduct clinical trials
- Requirements for clinical trial study sites
- How the process will be monitored
- The importance of patient privacy
- Additional protections for children
Find a Trial Near You
International Research Services, Inc. (IRSI) is committed to providing personalized and professional clinical trial services to cosmetic and pharmaceutical enterprises of any scale.Our attention is always focused on subject safety, regulatory compliance, quality of results and exemplary customer service.IRSI is a leader in biophysical instrumental analysis on the effects of test products on human skin.In addition, IRSI has phase I-IV Rx and OTC trial experience in numerous other clinical indications including acid indigestion, diabetes, weight loss, constipation, colds,coughs, smoking cessation, pediatric safety testing and odor threshold tolerance.
To arrange for a visit or for any additional information, please call 914-417-4112 or 914-937-9483 or email info@irsi.org.
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