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Drugs
The statutory definition of a
drug emphasizes the fact that they are: 1) articles
“intended” for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease; 2) articles recognized in
the U.S. Pharmacopeia, the U. S. Homeopathic Pharmacopeia, or
the National Formulary; 3) articles (other than food) intended
to affect the structure or any function of the body of man or
other animals; and 4) articles intended for use as a component
of any of the above. It is the intended use which
determines whether an article is a drug and is subject to the
drug requirements of the law if therapeutic claims are made on
them.
Before a drug or new drug may be
marketed, it must be approved by FDA. The world of FDA drug
approval can be divided into six basic categories: new drugs,
abbreviated new drugs, over-the-counter (OTC), new animal drugs,
abbreviated new animal drugs, and biologics. There is not one
single FDA approval process that applies to all drugs, but a set
of processes, each applying to different kinds of products with
important elements in common, but also some key differences. CCS
offers a range of pharmaceutical consulting, submission and
auditing services including:
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