Congressional obstacle for Reagan-Udall Foundation
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...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
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.
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.
The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.
The US MFN executive order is the latest in a series of concerning US developments that are contributing to uncertainty for the European pharmaceutical industry, according to France Biotech’s vice president, Alexandre Regniault.
Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.