In response, the U.S. Congress passed the Federal Food, Drug and Cosmetic Act of 1938, granting FDA with “premarket review” ...

Feldman and Schor explain that the patent dance is a complex process to determine which of a biologic manufacturer’s patents ...

Today, as Penn Carey Law celebrates the entire Class of 2025, The Regulatory Review is pleased to share this special ...

As the United States braces for what is likely to be another record-setting hurricane and wildfire season, one critical issue ...

A federal consumer protection agency's withdrawal of numerous guidance documents will have little legal effect.

In a conversation with The Regulatory Review, public health expert Mitch Zeller reflects on his tenure at the U.S. Food and ...

President Trump signed four Congressional Review Act resolutions into law, repealing Biden-era regulations on energy ...

When an agency issues or repeals a rule, it must undergo a set of procedures laid out in the Administrative Procedure Act (APA). Among these procedures is notice and comment, which involves notifying ...

The United Nations Secretary-General’s High-level Advisory Body on AI (HLAB) recently released its final report evaluating ...

For a recent paper, we reviewed the thousands of public comments sent to federal agencies in 35 rulemakings and found more stories than we could ever have imagined. Not only that, many stories ...