FDA Watch: Agency Opens New Pathway for STI At-Home Sample Collection Kits
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
From - Lab Compliance Advisor
April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for…
From - Lab Compliance Advisor
While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the…