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Food and Drug Administration (FDA) › Pharmaceutical Industry › White Papers

Arnall Golden Gregory LLP

Welcome to the Machine: FDA Issues White Paper on AI and Medical Products

Arnall Golden Gregory LLP on

For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more

Sheppard Mullin Richter & Hampton LLP

FDA White Paper Signals Shift to Performance-Based Reviews of Mature Quality Systems

Sheppard Mullin Richter & Hampton LLP on

The US Food and Drug Administration (FDA) Office of Pharmaceutical Quality (OPQ) of the Center for Drug Evaluation and Research (CDER) recently published a White Paper laying out a framework to evaluate the Quality Management...more

Goodwin

White Paper Investigates Biosimilar Competition and Price Reduction

Goodwin on

In March 2021, researchers from Harvard Medical School, Harvard University, and Brigham and Women’s Hospital published a white paper exploring the link between entry of biosimilars under The Biological Price Competition and...more

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