This article was originally published in The Tan Sheet
Company offers to delete statement "Healthy long-term joint support" from Inholtra Joint Pain, Joint Pain Plus dietary supplement/OTC combo products "if necessary to resolve all issues raised" by FDA, firm tells agency in Feb. 13 letter. Omni also says "active/inactive" distinction FDA made in its Feb. 8 letter is invalid because DSHEA authorizes use of supplements intended to affect structure, function of the body "without subjecting them to regulation as drug ingredients" (1"The Tan Sheet" Feb 18, 2002, p. 7). Company notes it "remains willing to meet with FDA to resolve outstanding issues"...
You may also be interested in...
B.F. Ascher has discontinued the sale of its Melagesic PM dietary supplement/OTC combination in response to FDA's decision the product is an unapproved new drug, according to the agency
Just five weeks before the US election, a Medtech Insight analysis shows medical device companies are spending more on Democrat Joe Biden’s campaign than on Republican Donald Trump’s.
Denmark’s Orphazyme has raised more funds to market its lead product, the heat shock protein amplifier, arimoclomol, in the US and Europe, and to evaluate the compound for other lysosomal storage and neurodegenerative disorders.