US FDA to propose new rule, guidance on e-submission of all drug study data
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration plans to propose by mid-2012 a new rule that would require drug companies to use an electronic format to submit all the study data that they include in their marketing applications1,2.
You may also be interested in...
Beovu & Recarbrio Among Five Drugs On Track For EU-Wide Approval
Five new drugs have been recommended for EU approval at the latest meeting of European Medicines Agency’s drug evaluation committee.
EU Preserves Status Quo On Drugs Under Additional Monitoring
The European Commission has set aside, for now, concerns expressed by member states regarding the scope of medicines subjected to additional monitoring requirements.
Singapore And Malaysia Test Joint Evaluation
A new work sharing pilot has been launched to evaluate jointly generic drugs intended for launch in Singapore and Malaysia.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: