Manufacturing Oversight: How FDA Ensures Generic Drug Safety
Explore how the FDA ensures generic drug safety through rigorous manufacturing oversight, bioequivalence testing, and global inspections under the Hatch-Waxman Act and GDUFA frameworks.
Explore how the FDA ensures generic drug safety through rigorous manufacturing oversight, bioequivalence testing, and global inspections under the Hatch-Waxman Act and GDUFA frameworks.