View EO 12866 Meeting 0910-AI85

  Medical Devices; Laboratory Developed Tests

  0910-HHS/FDA

  Proposed Rule Stage

  08/10/2023 11:30 AM

  Innovation Policy Solutions   Megan Anderson Brooks   Association for Molecular Pathology


 
List of Documents
Association for Molecular Pathology Meeting Slides 8.9.23
AMPResponseFDACaseReportFinal
Senate HELP 2016 hearing transcript; Laboratory testing in the era of precision medicine
Comparison of Laboratory-Developed Tests and FDA-Approved Assays for BRAF, EGFR, and KRAS Testing - PMC
HHS-Legal-Memo-on-LDTs-by-Charrow-00864663
 
List of Attendees Participation
•   Julie Wise   - OMB Teleconference 
•   Ariel Seeley   - FDA Teleconference 
•   Kevin Kho   - FDA Teleconference 
•   Christina Zielke  -  HHS Teleconference 
•   Jane Wargo   - HHS Teleconference 
•   Mary Busch   - FDA Teleconference 
•   Carrie Doupnik   - FDA Teleconference 
•   Eitan Bernstein   - FDA Teleconference 
•   Elizabeth Hillebrenner   - FDA Teleconference 
•   Sara Beardsley   - FDA Teleconference 
•   Sheri Walker   - FDA Teleconference 
•   Mary Williams  - Association for Molecular Pathology Teleconference 
•   Annie Scrimenti  - Association for Molecular Pathology Teleconference 
•   Dr. Megan Anderson Brooks  - Innovation Policy Solutions Teleconference 
•   Jennifer Leib  - Innovation Policy Solutions Teleconference 
•   Dr. Eric Konnick  - Association for Molecular Pathology Teleconference 
•   Dr. Monika Franco  - Association for Molecular Pathology Teleconference 
•   Samantha Pettersen  - Association for Molecular Pathology Teleconference 
•   Lindsey Trischler  - Innovation Policy Solutions Teleconference