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

By Kelly Lienhard / April 28, 2021 at 3:45 PM
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...

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