Pew To HHS: Reverse Azar Memo, Seek Bill On FDA Diagnostic Oversight

Pew Charitable Trusts is urging HHS to walk back its previous decision under the Trump administration to strip FDA of its ability to regulate of laboratory-developed tests before they hit the market, saying the policy elimination is “short-sighted” and hinders FDA’s ability to protect patients. The research group also asks HHS Head Xavier Becerra in a letter Wednesday (April 28) to back legislative reforms that would create a universal FDA regulatory framework for both LDTs and commercial tests. LDT developers...