Lack of robust regulations for generic drugs warning labels leads to outcry

Abstract:

An original drug manufacturer seeking new drug approval from the FDA is responsible for accurately and adequately labeling the new drug. A manufacturer of a generic drug is only responsible for making sure its warning label is the same as the reference drug. This has led to an outcry from patients and drug manufacturers as generics makers cannot be held legally responsible for any product defects. Both groups are demanding a change in current generics warning label regulations by the FDA.

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