It seems like the Section 520 of FDC&A is hided from public, or is it out of date?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)

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)

