RE: RE: Placebo Contribution from Ian written on 9/7/2010 at 22:08
Original contribution: RE: Placebo written by Yahoo on 9/7/2010 at 18:27) Yahoo is correct in that a Placebo is considered to be equivalent to a product containing the active drug substance. 21 CFR 210b) 4 indicates the following… “Drug product means a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.”
Clearly the FDA regard a placebo as a drug product if such a placebo is to be used for human administration.
Answering this Contribution:
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