CBER CONTEMPLATING ELIMINATION OF ELA FOR 39424"WELL-CHARACTERIZED" BIOLOGICS, FDA reported in a July 11 Federal Register notice announcing a guidance on the use of pilot manufacturing facilities for marketing approval of biologics. "The agency is currently considering changing its procedures to eliminate the requirement for a separate establishment license for certain well-defined classes of biologic products," the notice states. "Because of recent scientific advances, both in methods of manufacture and in methods of analysis, some products developed through biotechnology can be characterized in ways not historically considered possible," FDA explained. "Thus, the agency is considering allowing `biotech' products that are well characterized to be regulated under a single application."
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
