April 29, 2024

Office of New Drugs (OND) | Annual Reports

The 2023 OND Annual report captures the office’s achievements, including notable drug approvals, guidances, publications, and staff’s involvement in public meetings, workshops, webinars, and conferences. This […]
April 29, 2024

What’s New in Regulatory Science

Several times a year the Center for Drug Evaluation and Research sends out an update to share information on new developments, opportunities, and initiatives in regulatory […]
April 26, 2024

FDA Roundup: April 26, 2024

For Immediate Release: April 26, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]
April 26, 2024

Important Addresses for Regulatory Submissions

Address for Regulatory Submissions Food and Drug Administration,Center for Drug Evaluation and Research,Division of XXXXX,5901-B Ammendale Road,Beltsville, MD 20705-1266. Investigational New Drug (IND) Applications Therapeutic Biological […]
April 26, 2024

Therapeutic Biologics Applications (BLA)

 1999-2003 BLA information is available in the FDA Archive The therapeutic biological products include: Monoclonal antibodies for in-vivo use Cytokines, growth factors, enzymes, immunomodulators; and thrombolytics […]
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