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September 25, 2024

BsUFA II: Fiscal Years 2018 – 2022

The current legislative authority for BsUFA, authorized in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA) will expire in September 2017. The […]
September 25, 2024

Pharmaceutical Quality Resources

Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications. The Center for Drug Evaluation […]
September 25, 2024

Industry Resources

FDA provides information to assist industry in the development of generic drugs and submission of abbreviated new drug applications (ANDAs). This section includes links to summary […]
September 25, 2024

Generic Drug Development

Potential ANDA applicants are encouraged to contact the FDA Generic Drugs Program with questions at any point in their development and application preparation processes. If you […]
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