Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA OTC Drugs Of Abuse Screening Kit Guide Clarifies Cost Bundling

This article was originally published in The Tan Sheet

Executive Summary

FDA does not advise that OTC device manufacturers bundle the cost of primary and confirmation tests for home-use drugs of abuse test kits, the agency states in a draft guidance published in the Federal Register Dec. 2

You may also be interested in...



OTC Drugs-Of-Abuse Assay Firms Should Provide Confirmatory Testing - Panel

FDA should require manufacturers of OTC screening tests for drugs-of-abuse to cover the cost of confirmatory testing for presumptive positive results, members of FDA's Clinical Chemistry & Clinical Toxicology Devices panel recommended.

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

In Brief

Combe sells most of its OTC brands

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS096244

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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