FDA Watch: Scientists Ask Agency to Rescind Approval for Opioid Management Test
Experts—including those in genetics and device regulation—say the AvertD assay did not predict risks of abuse ‘any better than chance’
Experts—including those in genetics and device regulation—say the AvertD assay did not predict risks of abuse ‘any better than chance’
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.
According to the FDA’s recently-released annual report, only 135 devices received the designation last year, versus 213 in 2021.
The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.
In this month’s diagnostics pipeline report, Roche gets clearance for two new Alzheimer’s early detection tests.
A roundup of the significant new diagnostic tests and products that received regulatory approval in the US and around the world.
In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.