Resources

Resources

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 – Proposed Revisions to 2005 Final Rule on Public Health Service 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

FDA Final Rule – Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

FDA Draft Guidance – Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies