An FDA Overreaction to Theranos's Implosion Would Harm Patients
Briefly

The FDA is proposing a new rule that would require agency approval prior to the implementation of any LDT. Some proponents believe this approval could have prevented Theranos's deception with its diagnostic claims.
A Harvard Medical School psychiatrist warns that the FDA's proposed rule may lead to more harm than good, suggesting a more intensive validation program for LDTs instead.
Read at www.scientificamerican.com
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