Too Soon To Say If US FDA Device Reforms Are Working, Says Independent Report
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration has adopted all of the recommendations that consulting firm Booz Allen Hamilton has made in the past two years to improve its medical device review process, but it is still too early to say if the changes have improved overall performance.
You may also be interested in...
Industry, US FDA Strike $1Bn Deal After Contentious User-Fee Negotiations
FDA and industry have finally struck a tentative deal that, with Congressional approval, aims to raise nearly a billion dollars over five years. It also holds FDA to higher quality metrics while starting a pilot project to use real-world evidence in tracking devices on the market.
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.