FDA Sets New Limits on EUA Requests for COVID-19 Tests
The agency recently stated that current testing capacity is adequate and established limits on its review of new EUA submissions.
Already a member? Log in here
FDA Watch: New Guidance on Charging for Investigational Drugs
On August 21, the FDA proposed new guidelines on charging for investigational drugs; here are the key highlights.
Already a member? Log in here
Repeat At-Home COVID-19 Antigen Tests to Avoid False Negatives, FDA Says
The agency is advising people to perform repeat, or serial testing after a negative result, regardless of symptoms.
Already a member? Log in here
FDA Re-Opens Pre-Submission Requests for Non-COVID-19 IVD Tests
The agency is once more accepting pre-submissions for all in vitro diagnostic tests, not just those for COVID-19.
Already a member? Log in here
FDA to Continue Remote Regulatory Assessments after Pandemic Ends
Meant to be temporary, remote regulatory assessments proved so successful that the agency will not only continue, but expand their use.
Already a member? Log in here