US FDA consults on submitting "administratively complete" device PMAs
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration is seeking feedback on its proposal to ensure that medical device pre-market approval (PMA) applications are administratively and technically complete before they are accepted for full review1,2.
You may also be interested in...
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EMA Hopes New Requirement Will Make Companies Stick To Their Filing Plans
An additional form that marketing authorization applicants must now complete during the pre-submission stage emphasizes the importance of companies providing accurate information on their intended submission date.
EMA To Get The Ball Rolling On Making CTIS Global
The European Medicines Agency wants to further improve the visibility of data in the Clinical Trials Information System by establishing it as a World Health Organization primary registry.