FDA’s loosened up for Covid-19, possibly permanently

The fallout from the novel coronavirus might actually help the clinical trial process evolve: The biopharma industry and patient groups alike want to continue the regulatory flexibility that’s been granted thanks to Covid-19 — even when pandemic times are past.

“There is a pressing need for FDA and industry to identify actions taken during the Covid-19 pandemic and evaluate their effectiveness and applicability to innovative drug development beyond the public health emergency,” one PhRMA exec said during a public meeting Thursday.

The industry group told regulators that the FDA needs to embrace digital technology like telehealth and wearables, STAT’s Nicholas Florko writes, to help conduct decentralized clinical trials during the pandemic.