FDA recently published a new proposed rule in the Federal Register that will be open to comments until May 28th, 2013. The rule proposes an amendment to the regulations at 21 CFR Parts 807, 812, and 814 pertaining to the acceptability of data collected inside and outside of the U.S. that will be used to support a marketing application (IDE, 510(k), PMA, etc.). Surprisingly, the regulations currently do not fully address the requirements for either.
As stated in the proposed rule, “FDA believes that the requirements for FDA's acceptance of data from clinical studies should be consistent regardless of the type of submission or application in which the data are submitted to FDA.”
- If adopted, the amended regulations would rectify this by creating a requirement that data collected outside the U.S. would need to have been collected under the auspices of good clinical practice (GCP) in order to be accepted for any marketing application.
- In addition, it would further clarify the requirements for data collected inside the U.S. by officially aligning the requirements for IDEs and 510(k)s with those already specified for PMAs. The proposed rule cites numerous documents that have been released over the past two decades (ICH E6, ISO 14155, etc.) that provide additional safeguards for human subjects.
“Under the current regulations, in a study involving multinational investigational sites, several different standards may be followed leading to increased complexity in the conduct of the study.” FDA intends for the new rule to result in a “unifying approach” and hope it will simplify the regulatory burden on sponsors that have multinational sites in a clinical research study.
If the proposed rule becomes final, these ethical based documents would become further incorporated into the regulations. A move many might see as another step in the right direction when it comes to the protection of human subjects. However, there might be some others who see it as an additional hurdle or excessive scrutiny.
How do you feel about the proposed rule? Do you see the benefit of a unified approach? Will this lead to less regulatory burden for sponsors? We would love to hear your thoughts either way.
Photo Credit: mikecogh