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Dr. Pazdur’s New Role at CDER: More Than Just Adding Stable Leadership

Dr. Pazdur’s New Role at CDER: More Than Just Adding Stable Leadership

by Steven Grossman | Nov 19, 2025 | Short Takes and Updates

Dr. Pazdur’s New Role at CDER: More Than Just Adding Stable Leadership

Morale at FDA: Ready to Rebound or On a Downward Spiral?

by Steven Grossman | Nov 11, 2025 | Short Takes and Updates

Over the past two weeks, several news stories have reported low morale at FDA. Although they all reached the same conclusion, each story focused on a different driver. One was about how the shutdown was exacerbating low morale; another focused on the cumulative impact...
Dr. Pazdur’s New Role at CDER: More Than Just Adding Stable Leadership

FDA Is the Department of Homeland Security for Food and Drugs

by Steven Grossman | Oct 31, 2025 | Short Takes and Updates

To keep our country safe, counterterrorism efforts must be operational and effective 24/7/365. It only takes one terrorist at one specific moment to create a catastrophe.When it comes to food and medical products, FDA is our nation’s Department of Homeland Security....
Dr. Pazdur’s New Role at CDER: More Than Just Adding Stable Leadership

States vs. Federal Rights: The Perennial Debate Over FDA and Preemption

by Steven Grossman | Oct 24, 2025 | Short Takes and Updates

Since the founding of our republic, there has been debate about states’ rights vs federal rights. And in times of stress, the discussion gets more heated and gains more traction. Once again, FDA is moving into the center of such debates. Federalism is at the Heart of...
Dr. Pazdur’s New Role at CDER: More Than Just Adding Stable Leadership

FDA and the Revolving Door: Much Ado About Nothing?

by Steven Grossman | Oct 14, 2025 | Short Takes and Updates

The announcement that former CBER Director, Dr. Peter Marks, was joining Lilly as SVP for molecule discovery and head of infectious diseases….set the internet ablaze with unjustified outrage about his transition from a government career to industry. My multiple...
Dr. Pazdur’s New Role at CDER: More Than Just Adding Stable Leadership

Desperately Needed: Special Risk-Benefit Calculations for Relentlessly Progressive Chronic Diseases

by Steven Grossman | Oct 10, 2025 | Short Takes and Updates

Every day, our country is failing patients with relentlessly progressive chronic neurological, neuromuscular, and genetic diseases. Their plight necessitates a significantly different risk-benefit calculation than that of patients with other types of diseases....
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