Day: May 20, 2021

Almost all the products used to diagnose, prevent, and treat Covid infection, in the US, were authorized under the Emergency Use Authorizations (EUA), and now that the pandemic seems to be getting under control, at least in the US, it is critical that manufacturers of these products start thinking of life after the emergency both … Read more

FDA announced that in cases it is unable to conduct on-site Pre-Approval Inspections (PAIs), there are four possible outcomes for the applicants. This is to clarify a previous guidance document on the topic released last month. Applicants to plan and strategize accordingly. In a no-PAI situation, FDA may (1) approve the application, (2) issue a … Read more