Rep. Rosa DeLauro (D-Conn.) is asking FDA to stop all activities related to the creation of the Reagan-Udall Foundation until policies are established that safeguard against industry influence. The foundation was established by the FDA Amendments Act to advance the agency's Critical Path initiative and identify unmet scientific needs, but is currently unfunded. In a letter to FDA Nov. 1, DeLauro expresses concern that Critical Path activities, including those by the Reagan-Udall Foundation, could lead to the "approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials." The congresswoman further suggests that funds for the foundation be withheld until other FDA initiatives are fully funded...
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 European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
