Global Pharmaceutical Regulatory Agencies | Directory
Asphalion’s directory provides a comprehensive guide to these bodies around the world.
September 21, 2023
Asphalion’s directory provides a comprehensive guide to these bodies around the world.
The SDF is an extensible, portable text file encoding computer-readable chemical structures linked to associated data fields.
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This guidance provides recommendations to industry and FDA staff about the best practices of choosing a predicate device for a 510(k) submission. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).
Have a look at the slides to see how Asphalion´s expertise can help you with your regulatory
Recently, the U.S. Food and Drug Administration (FDA) made a notable advancement in protecting public health by
Are you planning to send a submission to the FDA? Will this submission contain study data? If
A lot of things have happened during these past three months. We received an award from AEFI
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