What is FDA?

Elham Tabassi on the challenge facing any new AI regulator, contrasting it with mature agencies like the FDA.

“This body or whatever body is being stood up is being asked to build the ruler and use it both at the same time. And do that for object of measurement that is changing faster than we can figure out how to build the ruler and use that.”

Only 9 drugs have been approved exclusively for children by the EMA and FDA combined over the last 20 years.

“In the last 20 years there's only been nine approvals exclusively for children from the EMA and the FDA in the USA.”

Steve Usdin flags an apparently unprecedented White House lawyer presence at a meeting about a product under FDA review.

“I found that on May twenty-seven, Replimune's CEO, Sushil Patel, met with FDA's acting chief of staff and chief counsel. Those are both political appointees. Josh Hoyt, associate counsel in the Executive Office of the President, also attended the meeting. That's really unusual, maybe unprecedented. I've never seen it before that a, a White House lawyer attends a, a meeting about a product approval with two political appointees.”

The FDA approved vagus nerve stimulation for rheumatoid arthritis before the supporting trial results were even published.

“Prior to the publication even the FDA gave approval this just last year months ago for the first time for a inflammatory autoimmune disease that vag nerve stimulation was given FDA approval.”

Replimune: its CEO met on May 27 with two FDA political appointees and a White House lawyer about a product under review, a potentially unprecedented political entanglement in a regulatory decision.

“I found that on May twenty-seven, Replimune's CEO, Sushil Patel, met with FDA's acting chief of staff and chief counsel. Those are both political appointees. Josh Hoyt, associate counsel in the Executive Office of the President, also attended the meeting. That's really unusual, maybe unprecedented. I've never seen it before that a, a White House lawyer attends a, a meeting about a product approval with two political appointees.”

Gain Therapeutics is developing GT02287, a first-in-class disease-modifying Parkinson's therapy, with an IND before the FDA and a Phase 1B biomarker signal already in hand.

“We have an IND before the FDA that we're expecting to get cleared this quarter.”

Gain Therapeutics expects FDA clearance of its IND for GT02287 in Q3 2026.

“We have an IND before the FDA that we're expecting to get cleared this quarter.”

Under Operation TrialBlazer's best-case scenario, the U.S. Phase I trial launch timeline would drop to roughly 15 months, less than half the current duration but still about 7 months longer than China's equivalent process.

“The timeline in the best case scenario in the United States to launch a, a Phase I trial would decrease to about fifteen months. Good news is that's less than half of what it takes now.”

Marty Makary's claim that all CNPV designations originated from FDA staff recommendations is contradicted by the TZIELD case, where neither Sanofi nor FDA staff requested the designation.

“He says neither Sanofi nor FDA staff asked for the CNPV designation. So Makary's statement that all of these designations came from staff, at least in this case, weren't true.”

The FDA no longer requires animal studies before first-in-human clinical trials, a significant regulatory shift for drug developers.

“You do not have to do animal studies anymore to do your first in human according to the FDA.”