Genetically Engineered Generic Drugs to Be Unleashed Without Mandatory Testing
Sunday, 12 February 2012 10:24
'Under the healthcare reform of 2010, the FDA was given the authority to regulate generic versions of genetically engineered (GE) drugs.
Furthermore, some genetically engineered drugs may not even receive human or animal testing — it all depends on whether or not the FDA deems it necessary.
The FDA is proposing new guidelines — an ‘abbreviated pathway’ — for generic drug makers to make similar, but not necessarily identical, generic drugs called ‘biosimilars’. The FDA will accept the drug studies from the original GE drug for approval, and will only require animal or human testing if the FDA deems it appropriate.'
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