In Brief: Psychemedics
This article was originally published in The Tan Sheet
Executive Summary
Psychemedics: Shipping PDT-90 personal drug test to Walgreen's. The 2,200-store chain is the first to offer the test, which previously sold via a toll-free number. The test analyzes a hair sample up to 90 days after removal to determine illegal drug use, including cocaine, marijuana, opiates, PCP and methamphetamine. FDA is expected to publish a proposed rule on OTC drugs of abuse tests in the next several months ("The Tan Sheet" Feb. 10, p. 16). The products now are being marketed under an interim policy in which FDA said it would not take action against unapproved OTC drug tests as long as they meet basic quality criteria. In August 1995, FDA sent a warning letter to Psychemedics stating that the PDT-90 test was an unapproved medical device; the agency later withdrew the letter in exchange for the firm's dismissal of a lawsuit against FDA, Psychemedics said in a Securities & Exchange Commission filing...
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Psychemedics: Shipping PDT-90 personal drug test to Walgreen's. The 2,200-store chain is the first to offer the test, which previously sold via a toll-free number. The test analyzes a hair sample up to 90 days after removal to determine illegal drug use, including cocaine, marijuana, opiates, PCP and methamphetamine. FDA is expected to publish a proposed rule on OTC drugs of abuse tests in the next several months ("The Tan Sheet" Feb. 10, p. 16). The products now are being marketed under an interim policy in which FDA said it would not take action against unapproved OTC drug tests as long as they meet basic quality criteria. In August 1995, FDA sent a warning letter to Psychemedics stating that the PDT-90 test was an unapproved medical device; the agency later withdrew the letter in exchange for the firm's dismissal of a lawsuit against FDA, Psychemedics said in a Securities & Exchange Commission filing.... |