Bioequivalency Generic Drugs Packaging Production 
FDA Law Blog
MARCH 5, 2023
Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. As part of its Generic Drug User Fee Amendments of 2022 (“GDUFA III”) Commitment, FDA agreed to expedited development of PSGs.
Pharmacy Checkers
FEBRUARY 14, 2020
In fact, they asked ConsumerLab.com, sister company to PharmacyChecker, to test the product. Sure enough, ConsumerLab.com discovered that the 300mg version was clearly not bioequivalent. Product of Canada; Manufactured by Valeant Pharmaceuticals $60.00* Product of Canada; Manufactured by Valeant Pharmaceuticals $42.90
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