JD Supra

Court gives new life to the post-CRL administrative hearing process, rules that FDA can deny hearing only when evidence is ‘conclusively deficient’

On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence ...
JD Supra

Supreme Court Determines That Constitutionality of FTC’s Administrative Review Process Can Be Challenged in Federal District Court

The Federal Trade Commission (FTC) has the distinct advantage of being able to bring enforcement actions before its own administrative tribunals. The FTC rarely loses a case brought through this ...
Law

Excessive Red Tape: Let's Curb Needless Administrative Process

It’s a good bet that when one party to a lawsuit wants a case remanded to an administrative agency, it’s the defendant. That’s because one of the primary effects of a remand is delay. But defendants ...
Washington Times

Supreme Court takes on the administrative state and power-hungry bureaucrats

Justice Clarence Thomas sent a warning shot across the bow of the expansive administrative state in a recent opinion suggesting it was time the court upend the litany of agencies that act as ...