Hold These Truths with Dan Crenshaw cover image

Reforming Our Nation’s Health Agencies in the Aftermath of COVID-19 | Scott Gottlieb, MD

Hold These Truths with Dan Crenshaw

CHAPTER

The Problem With the FDA's Decision to Approve Spinal Punctures

I talk to companies all the time who are just frustrated by this. I'm talking about really simple stuff. The FDA is like they almost don't want to give you the information. It's almost like a combative relationship as opposed to a partnership, which is deeply frustrating to the industry. Some parts of the agency do a better job of providing objective guidance on how to design clinical trials that will ultimately meet regulatory requirements.

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