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Fda Review Insights

Viewing all entries for: FDA Review

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Whitepapers

What Can Institutions with Local IRBs Do to Prepare for a Proposed FDA Single IRB Mandate?

Read More about What Can Institutions with Local IRBs Do to Prepare for a Proposed FDA Single IRB Mandate?
Whitepapers

Reviewing the FDA’s Proposed Single IRB Mandate

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Whitepapers

Reviewing the FDA’s Proposed Informed Consent Rule Changes

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Understanding the FDA’s new proposed regulations on human subject research and their impact on your clinical trial plans

Read More about Understanding the FDA’s new proposed regulations on human subject research and their impact on your clinical trial plans
Blog Posts

Assessing Potential Risks in the Consideration of IND Exemption Criteria

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Blog Posts

Defining “Minimal Risk” in Clinical Research

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Which comes first – IRB or IBC approval?

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Approval of an Investigational New Drug Study

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Whitepapers

Drafting a Research Plan for IRB Review and Research Conduct: Information that Must Be Included in a Clinical Trial Protocol

Read More about Drafting a Research Plan for IRB Review and Research Conduct: Information that Must Be Included in a Clinical Trial Protocol
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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?
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