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Summary DOJ NIH Rules on Sensitive Data Access
Sample IRB Guidelines for Investigators – Funding Agency Stop Work Orders
Comparison of FDA Regulations (Current and Proposed) & Common Rule
Summary of Proposed Changes – FDA Regulations 21 CFR 50, 21 CFR 56, and 21 CFR 812: Protection of Human Subjects and Institutional Review Boards
FDA Final Rule – FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests
Update – Clinical Decision Support Software Final Guidance
New changes to NIH Guidance on Flexibilities for Conducting Semiannual Program Review and Inspections
Office of Research Integrity – Final Rule Updating the PHS Policies on Research Misconduct
FDA Proposed Rule: Investigational New Drug Applications: Exemptions for Clinical Investigations to Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement or Cosmetic
FDA Proposed Rule – Medical Devices and Laboratory Developed Tests
Recent Posts
- Sample IRB Guidelines for Investigators – Funding Agency Stop Work Orders
- Understanding the Updated Final Rule on Research Misconduct: Key Changes and Institutional Impacts
- The Role of AI in Clinical Research: Boosting Efficiency and Addressing Compliance Challenges
- Exception Process for Revised Common Rule Single IRB RequirementComparison of Common Rule_FDA_Revised FDA_May 2024Exception Process for Revised Common Rule Single IRB Requirement
- Navigating the Complexities of Exception from Informed Consent (EFIC) in Research
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