Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Review Pathway
Oncology Center of Excellence pilot program is intended to make the single patient IND process easier to navigate and more efficient; regulatory project managers will help walk providers through the process and provide contact information for drug companies and institutional review boards.
J&J’s treatment-resistant depression drug esketamine had an easy time at an FDA advisory committee despite raising some tough regulatory questions. If you are looking for a showcase of how “Breakthrough” drug development collaboration can help a new therapy get to patients faster, this might be it.
Accelerated assessment requests at the European Medicines Agency.
The European Medicines Agency will fast-track Shionogi’s new antibiotic, , through regulatory review when the company files for approval but there’s no special treatment for Roche’s new tissue agnostic oncologic, . More than half the accelerated assessment requests made in 2018 to the EMA failed to make the grade.
All set! This article has been sent to firstname.lastname@example.org.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.