Confine or Seclude Participants in Bioequivalence Trials, FDA Guidance Says
Sponsors of generic drug products that need to conduct bioequivalence (BE) trials during the COVID-19 pandemic should develop site-specific plans to either quarantine or separate participants to minimize their exposure to the virus, according to a final guidance released by the FDA last week.
The guidance, intended to be in effect only for the duration of the public health emergency, directs sponsors that want to start or resume BE studies interrupted by the pandemic to use one of two trial models.
The first, a confinement or “bubble” design, confines staff and participants to the trial facility for the duration of the trial. The second nonconfinement, or “ambulatory,” design schedules procedures at times and locations so that no two participants come into contact and there is time to clean equipment and facilities between visits.
Comments on the guidance may be submitted at any time.
Read the guidance at https://bit.ly/35JMNnz.