"Ten Myths and Facts about Defective Drug Injury Claims: What Every Consumer Needs to Know" by Peter Brodhead provides useful information that will help the consumer understand, in a general way:
An overview of the FDA's approval process;
An overview of what FDA approval of a new drug does and does not mean;
The difference between FDA-approved uses for a drug and "off-label" uses of a drug;
Important differences between a brand name drug and a generic drug; and
Factors you may wish to consider when selecting an attorney to proceed with a claim.
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