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...
Global Regulators Issue Advice On Clinical Comparability Of Biosimilar MAbs
The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.
Global Pharma Industry Regulators Seek Unified Approach To Remote Inspections
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.
Canada Boosts Postmarket Device Safety With New Reporting Rules
Device companies operating in Canada are being advised to review their internal procedures in anticipation of new postmarket requirements that come into force this year.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: