Under the Generic Drug User Fee Amendments (GDUFA), facility readiness and goal date decisions are key components of the regulatory framework governing generic drug approval processes in the United States.
Under the Generic Drug User Fee Amendments (GDUFA), facility readiness and goal date decisions are key components of the regulatory framework governing generic drug approval processes in the United States.
Content and Format of Composition in Labeling : NDA's-ANDA's
MAPP - Generic Drug Labeling Revisions Under Section 505(j)(10) of the FFD& C Act
Portable Document Format (PDF) Specifications
What is a suitability petition?