Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA Seeks Civil Money Penalties From Worldwide Medical, Firm's Executives

This article was originally published in The Gray Sheet

Executive Summary

FDA affirmed its regulatory authority over home-use drugs-of-abuse assays in an October 1999 letter to Worldwide Medical that preceded its recent civil money penalty action against the firm, FDA reports.

You may also be interested in...



Disgorgement Offers "Innovative Approach" To GMP Compliance - FDA

FDA will look to recover profits from companies as a penalty for regulatory violations even in cases not involving the future sales of products deemed medically necessary.

Disgorgement Offers "Innovative Approach" To GMP Compliance - FDA

FDA will look to recover profits from companies as a penalty for regulatory violations even in cases not involving the future sales of products deemed medically necessary.

First Check

Worldwide Medical announces U.S. launch of the cholesterol home screening product June 5. First Check tests will retail for $14.99 each, and a two-test kit will sell for $24.99. Lake Forest, California company also signs a distribution agreement with Kroger to carry two First Check drugs of abuse (DOA) tests in the chain's food and drug outlets. Worldwide began marketing the First Check OTC line, which also includes tests for alcohol and colorectal disease, in 1997. First Check received clearance via 510(k) last year, but the firm has been at odds with FDA over regulatory authority for the home-use DOA tests. FDA lodged a Feb. 2 complaint seeking over $3 mil. in civil money penalties, claiming that Worldwide Medical marketed the tests without clearance between July 14, 1999 and June 20, 2000 (1"The Gray Sheet" Feb. 12, 2001, p. 16)

Related Content

UsernamePublicRestriction

Register

MT014467

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel