Would-Be FDA 'Maturity Model' Pilot Might Reward Firms With Delayed Inspections
This article was originally published in The Gray Sheet
Executive Summary
"Mature" device manufacturers could put off an FDA inspection for a few years if they independently verify that they have robust quality metrics in place under a potential pilot program, CDRH's new compliance head says. The pilot would be part of FDA's plan under its Case for Quality to use a maturity model to prioritize facility inspections.
You may also be interested in...
Trump Signs Bill Bolstering US FDA Device Center Funding By 2% To $8M
The FDA’s device center is getting a 2% boost after President Trump on 20 December signed off on all appropriations bills for fiscal year 2020.
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.