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New CBER Leadership: The FDA Matters Analysis

New CBER Leadership: The FDA Matters Analysis

by Steven Grossman | May 8, 2025 | Short Takes and Updates

The headline, “Dr. Prasad to succeed Peter Marks as CBER director,” spread like wildfire Tuesday night after Endpoints News broke the story. Reactions ranged from “Omigod, he’ll destroy the industry and the hopes of patients” to “no big deal, staff do the product...
New CBER Leadership: The FDA Matters Analysis

Truth-Telling: FDA User Fee Edition

by Steven Grossman | May 2, 2025 | Short Takes and Updates

After 50 years in Washington, I have no expectation of being told the truth by government officials—elected or appointed. I like to think I have seen it all—shading the truth, burying the truth, plausibly deniable truth, and sometimes things entirely made up and...
New CBER Leadership: The FDA Matters Analysis

The American People in the Hands of an Indifferent Government

by Steven Grossman | Apr 29, 2025 | Short Takes and Updates

Several decades ago, when I was a Senate staffer, I observed that I could spend the entire Gross Domestic Product on the good ideas that people brought to us. I soon learned that lawmaking requires a substantial amount of restraint and a lot of prioritizing. Those are...
New CBER Leadership: The FDA Matters Analysis

How Many People Still Work for FDA & Other FDA Thoughts

by Steven Grossman | Apr 25, 2025 | Short Takes and Updates

FDA’s responsibilities have not changed since January 20th. However, its capacity to carry out its duties has been meaningfully reduced by the Administration’s downsizing. We should all be able to agree on that. It has not been clear how many people still work...
New CBER Leadership: The FDA Matters Analysis

FDA and Politics: An Unhealthy Combination

by Steven Grossman | Apr 22, 2025 | Short Takes and Updates

Dr. Makary is a physician, healthcare quality and outcomes researcher, and self-styled iconoclast. When he accepted the Commissioner position in November 2024[1], I am sure he believed that Trump 2.0 would be a hospitable place to harness those personal attributes in...
New CBER Leadership: The FDA Matters Analysis

Leaked FY 26 FDA Budget Document Explained

by Steven Grossman | Apr 17, 2025 | Short Takes and Updates

There is a document widely-circulated this morning that purports to be the OMB passback to HHS of the draft proposed FY 26 HHS President’s budget request. It includes proposed numbers for FDA funding for the coming fiscal year. It is still subject to negotiation...
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