1. Pink Sheet

On The Docket: Recent Submissions For US FDA Approval

 
• By Bridget Silverman

Round-up of late summer applications recently submitted to US FDA, adapted from the Pink Sheet FDA Performance Tracker's User Fee Goal Dates chart.

Below is a table from of recent NDA and BLA applications to the US Food and Drug Administration based on data from the Pink Sheet’s FDA Performance Tracker. As one might expect, special pathways figure prominently in the submissions.

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EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
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