Title: What are unapproved drugs and why are they on the market?
What are unapproved drugs and why are they on the market?
Fri, 21 May 2010 12:34:00 -0500
Federal law generally requires that drugs in the United States be shown to be both safe and effective prior to marketing. Drugs that are marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. For a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally in the United States without required FDA approval. Many healthcare providers are unaware of the unapproved status of these drugs and
have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval.
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