Still Mulling EUA Transition Options? Don’t Wait Too Long, Attorney Says
Executive Summary
Manufacturers whose COVID-19 related products reached market via the US FDA emergency use authorization pathway will soon face a choice as to whether to get additional clearances stay on the market or not. According to Alston and Bird attorney Ben Wolf, the time to prepare is now.
You may also be interested in...
Thinking Post-COVID: How Will US FDA Transition Drug, Vaccine EUAs To Full Approvals?
Sponsors seek clarity about the transition process, which could last a year or longer.
FDA Unveils 3-Phase Approach For Bringing Products Back Under Compliance After Pandemic Enforcement Leeway
The US FDA says in a new draft guidance document that makers of a variety of devices and diagnostics that were given wide enforcement berth by the agency to use their products to respond to COVID-19 must eventually transition back to full regulatory compliance under a proposed three-phase plan.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.