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 […]

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 […]

The Role of Scientific Consortia in Drug Development Background Information The Critical Path Initiative (CPI), and the Strategic Plan for Advancing Regulatory Science Initiative seek to […]

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 […]

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 […]

There are two regulatory pathways to bring a nonprescription drug to market in the U.S. — the drug application process and Over-the-Counter (OTC) Drug Review (OTC […]

 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 […]

FDA aspires to continually improve its pre-ANDA (abbreviated new drug application) interactions with applicants. To facilitate these interactions and keep stakeholders as informed as possible, the […]

CDER researchers have conducted a randomized study to better understand how physicians make prescribing decisions. As they make decisions about which drug products should be prescribed […]