How can I find the §513(a)(3)(D) and §520(g)(7) of FDC&A in this picture?

Mandy0528

Starting to get Involved
It seems like the Section 520 of FDC&A is hided from public, or is it out of date?
And also, the content of the Section 513 dose not include "Determination Meeting", so I am so confused.

The regulation of "Determination Meeting" and "Agreement Meeting" can be found in this Guidance: Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff.
Early Collaboration Meetings Under the FDA Modernization Act (FDAMA)

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EmiliaBedelia

Involved In Discussions
You are looking directly at the US Code. The section references in the consolidated code are different from the section references within the law itself - in the snip you provided, you need to look at Chapter 9 - FD&C Act.
On this page, you can find a cross-reference of the FD&C act to the US Code. FDAMA amended the FD&C act- so when you read the text of FDAMA, you will see that it calls out the sections of the FD&C that were amended.

All of this being said, if you are looking for information on how to actually go about setting up a meeting with FDA, the law itself is not the best resource. The way that the US regulations work, Congress passes a law (FDAMA/FD&C), then FDA makes regulations on how to actually implement this law at the agency level, and releases guidances/forms/documents/etc to set out the process for industry. The text in the Law that describes classification meetings is about a paragraph long - the Early Collaboration Meetings guidance that you were looking at is a better reference for what you actually need to do to have a meeting.
 
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