FDA and CMS issue statement on LDTs: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made

This joint statement notes the evolution of Laboratory Developed Tests (LDTs) from the initial rule and approach the FDA had for oversite, and today's environment with the extensive use of LDTs in medical decisions. Last October, the FDA issued a proposed rule change that would go from the historic practice of not enforcing all aspects of the LDT regulations and moving to enforcing the existing regulations.

The CMS portion of the announcement addresses it's role in the Clinical Laboratory Improvement Amendments of 1988 (CLIA) is separate and distinct from the FDA's role in the reviews of the analytical and clinical validity of LDTs.

This Link takes you to the announcement.

ACRO and Trancelerate release infographic on ICH E6(R3) Good Clinical Practice guideline vs R2

If you have or haven't looked at the ICH E6 revision 3 GCP guideline, this may be of interest to see how others perceive the differences from the current guideline.

 From the LinkedIn announcement:

TransCelerate is excited to announce the release of a new co-created resource! We have partnered with the Association of Clinical Research Organizations (ACRO) to release a new infographic that features the key changes to risk management in ICH E6 (R3) between Version 2 and 3.  

#goodclinicalpractice #acceleratinganswers #collaboration 

Learn more and check out the new infographic: https://lnkd.in/gGC-fJtR 

FDA and Health Canada hosting regional public meeting on ICH draft guidelines

 Prior to the next ICH Biannual Assembly meeting the FDA and Health Canada are hosting a virtual public meeting on 22February 2024 from 11:00 AM to 3 PM ET.

A large number of ICH guidelines that are reaching milestones are listed at the announcement website to be presented and discussed:

TOPICS COVERED

• ICH Background
• ICH Guidelines Reaching or Approaching Key Milestones
  • Q2(R2)/Q14 Revision of Q2(R1) Analytical Validation and Analytical Procedure Development
  • Q5(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
  • Q9(R1) Quality Risk Management
  • E6(R3) Good Clinical Practice Principles and Annex 1
  • M14, General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines
  • E2D(R1) Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
  • M12 Drug Interaction Studies
• ICH Cell and Gene Therapy Reflection Paper
• Q&A

The full agenda and registration are available at the website(https://www.fda.gov/drugs/news-events-human-drugs/joint-us-fda-health-canada-ich-public-meeting-02222024?utm_medium=email&utm_source=govdelivery)