Artificial intelligence continues to revolutionize virtually every facet of modern life, and healthcare is no exception. But ...

In this last installment of our series, we will provide practical advice on what it takes to successfully invoke the common law experimental use exemption and the statutory safe harbor during ...

The US FDA has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted to the agency from 2020 to 2024.