December 2022 FDA Watch: COPD, COVID-19, and MDD Tests Gain Clearance
A roundup of the significant new diagnostic tests and products that received regulatory approval in the US and around the world.
Already a member? Log in here
Want Breakthrough Device Designation? You’ll Need to Consider Health Equity
In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.
Already a member? Log in here
FDA Watch: Monkeypox, COVID-19, and MDD Tests
While new test approvals were scarce in October, they were particularly impactful; here are three approvals you should know about.
Already a member? Log in here
November 2022 FDA Watch: Pace of New Approvals Slows
Though there were fewer new approvals last month, the impact of the products that did gain approval more than made up for the drop in volume.
Already a member? Log in here
FDA Reopens EUA & Immediate EUA-Less Use Pipelines for Monkeypox Tests
Despite lessons learned from COVID-19 testing, HHS and FDA plan for monkeypox testing remains flawed.
Already a member? Log in here