HOME ACCESS' OTC HIV TESTING SERVICE SALES IN NEW YORK, CALIFORNIA MAY BE DELAYED BY STATE LAWS; FIRM SEEKS FEDERAL PREEMPTION RULING FROM FDA
This article was originally published in The Gray Sheet
Home Access Health's over-the-counter sales of its home HIV-1 testing service could be delayed in New York and California, two of the largest markets for the products, due to clinical testing requirements in the two states. The company submitted a request for an "expedited advisory opinion" to FDA on Aug. 16 seeking a determination that the agency's premarket approval of the tests preempts the state requirements.
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