FDA wants to boost take-up of third-party reviews
This article was originally published in Clinica
Executive Summary
The US FDA intends to expand the list of products that can participate in its third-party review programme, by early next year until at least 60% of all 510(k) submissions are eligible. Under the terms of the FDA Modernization Act, the third-party programme will end five years after the agency reaches that percentage, unless it is renewed by Congress.
You may also be interested in...
At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use
At the recent Precision Med-Tri Con conference, laboratory experts traded views on the expansion of at-home testing for disease diagnosis and personalized health insights. While strong consumer demand spells opportunity, there are significant concerns about the accuracy and reliability of home-testing platforms, misuse, accessibility, and lack of health literacy.
Simplified Clinical Trial Transparency Rules To Go Live In The EU In June
A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules.
Top-Selling Drugs 2023: Pharma’s $60bn COVID-19 Cliff
Pfizer/BioNTech’s COVID-19 vaccine Comirnaty toppled after recording the highest ever annual sales for a pharmaceutical in 2022, while Novo Nordisk’s Ozempic climbed rapidly. But Merck & Co’s immuno-oncology blockbuster Keytruda was secure in the number one spot in 2023 as COVID-19 receded.