An independent report on the US Food and Drug Administration’s COVID-19 response is spurring the agency to make some changes intended to improve how it handles emergency use authorization applications and communicates with industry.
FDA Plans To Improve COVID-19 EUA Process, Inspection Work Based On Report Recommendation
The agency is taking to heart several recommendations made by an independent reviewer earlier this year in a report on its COVID-19 response.

More from Regulation
More from Policy & Regulation
• By
The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.
• By
A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.
• By
Cybersecurity, sustainability and regulatory intelligence all need factoring into risk management today as AI and data availability change the goalposts. Eight experts tell Medtech Insight how compliance efforts must adapt.