The U.S. Food and Drug Administration has launched a project to overhaul its application development process to provide management with a view into the agency’s IT projects. The 12-month project, ...

This framework is the second that the agency has introduced in recent months to streamline biosimilar development in the ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...

Draft recommendations allow skipping at least one U.S.-reference comparative PK study when analytical and other evidence supports biosimilarity, including use of ex-U.S. comparator data in defined ...

When a development team is working on a piece of software, and they have a fundamental question about how the piece of software will be treated at FDA, the regulatory affairs professional cannot ...

The execution of the U.S. Army Medical Research and Materiel Command’s mission to create medical products for the warfighter is intricate. A product manager must adhere to a long list of acquisition ...

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...