On July 25, 2020, Claudia Lewis was featured on SupplyChainBrain discussing how the U.S. Food and Drug Administration (FDA) is revising its policies, practices, and regulations in response to the coronavirus pandemic.
According to Lewis, the pandemic has motivated the FDA to undertake some dramatic, if temporary, changes in its procedures. Some relaxation of rules and regulations have been allowed in order to meet heavy demand for personal protective equipment (PPE), drugs, and the ingredients of a still-developing vaccine. In response, the agency has quickly issued a number of guidance documents — around 40 in a matter of weeks. That’s in sharp contrast to the 18 months FDA usually takes to review rules under normal conditions.
Even the accelerated procedures are designed “to make sure we have the healthcare supply we need, but are still safe and effective,” Lewis says.
Click here to watch the interview.