In the past, the FDA only accepted clinical studies that were conducted in the United States. However, in recent years, the FDA has begun to accept clinical studies that were conducted in other countries. This is because the FDA recognizes that high-quality clinical studies can be conducted in other countries, and that accepting such data can help to speed up the drug development process.
There are a few conditions that must be met in order for the FDA to accept clinical studies that were not conducted under an IND. First, the study must have been conducted in accordance with Good Clinical Practice (GCP) standards. GCP is a set of international ethical and scientific quality guidelines for conducting clinical studies. Second, the FDA must be able to validate the data from the study. This can be done through an onsite inspection of the study site or by reviewing the study protocol and other documentation.
If the FDA accepts a clinical study that was not conducted under an IND, the data from the study will be considered along with other data from other studies in the review process. The FDA will weigh all of the available data to determine whether the product is safe and effective for its intended use.
The FDA’s acceptance of foreign clinical studies not conducted under an IND has made it easier for drug companies to develop and market new products. This is because it allows drug companies to conduct clinical studies in countries where it is more cost-effective to do so. Additionally, it allows drug companies to start marketing their products more quickly, which can benefit patients who need those products.
However, it is important to note that the FDA does not automatically accept all foreign clinical studies. The FDA will only accept studies that meet its high standards for safety and efficacy. If you are considering conducting a clinical study in another country, you should contact the FDA to discuss the requirements for acceptance. Vici Health Sciences is experienced in FDA correspondences and FDA meetings to discuss the foreign clinical trials data to determine the potential for acceptance to the US FDA.