Ask the FDA and CMS/CLIA

Program Chair(s)

• 

  Karen Palmer, MT(ASCP) CQA(ASQ)

  Director, Regulatory Affairs
  AABB
  Bethesda, Maryland, United States

  Disclosure(s): No financial relationships to disclose

  PDF

Speaker(s)

• O

  Orieji Illoh, MD, CBER, OBRR

  Disclosure information not submitted.
• CM

  Catherine McGraw, MSN, RN

  Consumer Safety Officer
  CBER, OBRR

  Disclosure(s): No financial relationships to disclose
• RE

  Racquel East, MS, MLS(ASCP)SBB, CBER, OBRR

  Clinical Laboratory Scientist
  CBER, OBRR
  Silver Spring, Maryland, United States

  Disclosure(s): No financial relationships to disclose
• IS

  Irma Sison, MD, MBA

  Director
  Division of Human Tissues
  Office of Therapeutic Products

  Disclosure(s): No financial relationships to disclose

This popular session consistently draws a large audience and provides an opportunity for the regulatory experts with the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services/Clinical Laboratory Improvement Amendments representatives to respond to member questions about new rules, regulations and guidance. The session also gives FDA an opportunity to present their current thinking on policies, regulations, guidance documents and inspection programs that are relevant to their oversight of blood and human cells, tissues and tissue-based products (HCT/P) programs. Questions for the session are submitted in advance to regulatory@aabb.org.