Diagnostics Pipeline: FDA Tweaks Quality System Regs to Align with Global Standards
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
Approval for OTC use of a urine drug test that can be performed by non-CLIA facilities could help expand accessibility, expert says.
Debate is underway on whether current CLIA review of LDTs properly assesses a test’s likelihood to detect diseases.
The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.
With recent test recalls announced by Universal Medtech and QuidelOrtho, such products now make up one-third of 2023 total recalls listed by the FDA.
The agency recently sent its own proposed LDTs regulation rule to the White House Office of Information and Regulatory Affairs for review.
New program aims to provide greater transparency on the recommended performance characteristics of such tests.
The agency recently announced it will decide in December whether to grant clearance for a CRISPR therapy for treating sickle cell disease.
In early May, GSK’s Arexvy became the first RSV vaccine to be cleared by the FDA for use in the US in adults aged 60 and up.
On March 27, the agency released a new guidance document to help test developers make the transition to full approval.
In the period from Mid-February through mid-March, three different products received first-of-their-kind clearances from the agency.