US FDA approval info sought for final Bush months
This article was originally published in SRA
Executive Summary
US congresswoman Rosa DeLauro (Democrat – Connecticut) has asked the acting Food and Drug Administration commissioner Frank Torti for information on drug and device approvals made in the final months of the Bush Administration, in an effort to ensure that the outgoing administration did not “impose their political will on agency decisions” before they left1.
You may also be interested in...
EU Accelerated Assessment Tracker
Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.
EU Accelerated Assessment Tracker
The EU filing for AstraZeneca’s nirsevimab is being reviewed under the accelerated pathway at the European Medicines Agency. Also, Janssen should know by now whether its planned filing for Zejula plus Zytiga will get the same treatment – as should SIFI for its planned Akantior filing.
AZ Secures EU Fast-Tack Review For Nirsevimab
There could be a regulatory decision on AstraZeneca and Sanofi's nirsevimab in the EU in H2 as a result of the European Medicines Agency speeding up its review of the marketing application for the potential new immunization against RSV in all infants.