Zicam Lawsuits Multiply, But Matrixx Is Confident History Will Repeat Itself
This article was originally published in The Tan Sheet
Matrixx Initiatives braces for new lawsuits alleging the firm's Zicam intranasal products cause anosmia - a loss of the sense of smell - following FDA's warning letter to the firm and consumer alert
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Revised draft guidance identifies types of homeopathics posing "higher risks to public health." FDA withdraws 1988 compliance policy guide that allows homeopathic to be available even though they are not subject to pre-market approval or other review process agency imposes on all other drugs.
Problems stated in a draft guidance where FDA will "prioritize enforcement and regulatory actions" includes products with routes of administration other than oral and topical or intended to be used for the prevention or treatment of serious or life-threatening diseases and conditions.
Products with routes of administration other than oral and topical or intended to be used for the prevention or treatment of serious or life-threatening diseases and conditions will be among those prioritized for enforcement and "regulatory actions," draft guidance notes.