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.
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A Successful FDA cGMP Inspection: The Six Steps of a Pre-Inspection Audit
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.
FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform
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…
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform
From - Lab Compliance Advisor
While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the…
