Attorney Points To Compounding Regs To Guide FDA In LDT Oversight

• Attorney Points To Compounding Regs To Guide FDA In LDT Oversight

  An industry attorney is urging FDA to use its drug compounding policies as a roadmap as it weighs how to oversee laboratory-developed tests. How the agency distinguishes between medical practice and manufacturing in the pharmaceutical compounding setting could guide the agency as it similarly tries to determine which LDTs should be regulated as medical devices, the attorney said at an FDA public meeting last week.

  706 words at https://healthpolicynewsstand.com/newsletters/fda-week
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