FDA will be able to give scientific advice and sponsors can familiarize reviewers with upcoming generic applications for complex products under new provision in GDUFA II.
The meeting process for ANDAs targeting complex products that FDA will implement during GDUFA II is intended to help agency reviewers as much as sponsors.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.
France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.
The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.
