The mandatory reporting—as required by statute—of adverse events and other information related to the quality, effectiveness and safety of FDA-regulated products
FDA recommends that the report number consist of 3 numbers separated by dashes. The first number will be the 10-digit FDA Establishment Identifier (FEI) number. The second number is the year that you are submitting the report. The last number would be a consecutive 5-digit number for each report filed during the year by the manufacturer. Example: 1234567890-2005-00005.
Medical Dictionary of Drug Regulatory Affairs
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Under the provisions of section 403(c) of the Federal Food, Drug, and Cosmetic Act, a food is considered to be misbranded if it is an imitation of another food unless its label bears, in type of uniform size and prominence, the word \"imitation\" and, immediately thereafter, the name of the food imitated. [Ref: 21CFR101, Sec. 101.1]
If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual. [Ref: Sec. 201. [21 U.S.C. 321] Chapter Ii—Definitions 1]
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