Compliance In Focus

It has been recognized by the FDA that Coronavirus Disease 2019 (COVID-19) pandemic may impact clinical trials for drugs, medical devices, and biologics. Site closure, quarantines, and travel limitations are just some of the prevention factors that may make it problematic to conduct clinical trials. Alternative approaches and considerations are needed at this time in order to assure the safety of trial patients, good clinical practice, data integrity, and minimize risk.

With the uncertainty of the coronavirus (COVID-19), the impact of this global health issue remains to be seen. Recently, the FDA issued a news release indicating that together with help from the centers for disease control (CDC), they are trying to make more respirators available for health care personnel. The CDC requested emergency use authorization (EUA) which would allow the use of certain industrial respirators in the healthcare setting. These normally would not be approved for use in the clinical setting; however, the FDA stated that “…they may be effective in preventing health care personnel for airborne exposure, including the COVID-19.” As more cases continue to develop locally as well as abroad, more directives and urgent measures may occur.