May might be the month that the FDA finally issues new rules that allow the agency to accept data from clinical studies outside the U.S.
The FDA is scheduled to release three new finalized regulations this month dealing with medical device trial data, postmarket safety reporting requirements for combination products, and revised regulation on what companies must register for their facilities and list medical products, according to the Regulatory Affairs Professional Society (RAPS)
Foreign Device Trial Data
The rule was first proposed in 2013 and is intended to update the standards to allow for the agency to accept data from clinical studies conducted outside the U.S.
The agency says it is also proposing to amend the IDE [investigational device exemption] and 510(k) regulations “to address the requirements for FDA acceptance of data from clinical studies conducted inside the U.S. The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type.
The final rule would rely upon conformance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC), and obtaining and documenting the freely given informed consent of study subjects.
Postmarket Reporting
The rule will clarify the postmarket safety reporting requirements that apply when drugs, devices and biologics are combined to create a combination product. RAPS reports that the rule “comes as significant advances have been made in the development of combo products over the past decade and as stakeholders have expressed concern about the lack of concrete information regarding the postmarketing safety reporting regulatory requirements of such products.”
The rule establishes various guidelines on what types of alerts and adverse events should be reported, as well as specific examples of different combo products and how information should be sent to FDA.
This final rule, first proposed in 2009, was set to be released sometime last month.
Facility Reporting Requirements
Drug and biologic manufacturers, importers, repackagers, relabelers and “salvagers of marketed drugs” may see new final regulations this month on how to report to FDA where their facilities are located and what products are being manufactured there.
Industry has been waiting for a decade for these new requirements.
