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Fda Review Insights

Viewing all entries for: fda review

  • Insights
    • Insights Archive
      • fda review
Ask the Experts

What are the requirements for notifications of study closure at research sites?

Read More about What are the requirements for notifications of study closure at research sites?
Ask the Experts

Do all subjects need to be reconsented with the revised consent form?

Read More about Do all subjects need to be reconsented with the revised consent form?
Ask the Experts

Can a protocol get IRB approval during the 30-day IND waiting period?

Read More about Can a protocol get IRB approval during the 30-day IND waiting period?
Whitepapers

The Basics of the Individual Expanded Access Request Process: A Resource for Physicians

Read More about The Basics of the Individual Expanded Access Request Process: A Resource for Physicians
guidance documentation Blog Posts

Key Takeaways From FDA’s New Draft Guidance, “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial”

Read More about Key Takeaways From FDA’s New Draft Guidance, “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial”
Ask the Experts

Can a physician submit a single humanitarian use device (HUD) submission to the IRB?

Read More about Can a physician submit a single humanitarian use device (HUD) submission to the IRB?
Ask the Experts

What documentation needs to be submitted to the IRB for an IND exemption request?

Read More about What documentation needs to be submitted to the IRB for an IND exemption request?
Ask the Experts

Can you provide an IRB approval before FDA’s review of the IND?

Read More about Can you provide an IRB approval before FDA’s review of the IND?
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