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Stephen Schwartz
March 30, 2020 Intelligence: Late-Breaking Lab News
Should consumers be allowed to collect their own specimens for a COVID-19 test? At least five companies announced plans in mid-March to sell COVID-19 tests directly to consumers and have them collect their specimens at home, then return the samples to the the labs doing the testing. This s…
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Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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