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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 […]
September 24, 2024

FDA Roundup: September 24, 2024

For Immediate Release: September 24, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]
August 15, 2024

Drug Trials Snapshots: IQIRVO

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]
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