3 ms·
From the article: It's inconceivable (to me, at least) that there are no laws requiring drug companies to list placebo ingredients. From CFR 21 Part 312.23 (a)
by hermannj314 14y ago
From the article:
It's inconceivable (to me, at least) that there are no laws requiring drug companies to list placebo ingredients.
From CFR 21 Part 312.23 (a)(7)(iv)(c):
A brief general description of the composition, manufacture, and control of any placebo used in a controlled clinical trial. [is required to be supplied for an Investigational New Drug Application]
What is the difference? It seems the law clearly states that for new drugs, you must list the composition of your placebo to the FDA. It would seem the article is mistaken. I am not a lawyer nor do I work in the pharmaceutical industry. I just did a google search for "placebo composition site:fda.gov"