Food and Drug Administration
The Office of New Drugs is the nexus where oversight of drug developments take place by bringing new product innovations to market.
Mission
The Office of New Drugs (OND) is a super office within the Center for Drug Evaluation and Research responsible for the assessment of new drugs and therapeutic biologics. OND provides clinical, nonclinical, and regulatory expertise on the full range of drugs and therapeutic biologics that can be made available to the American people. Our work begins when pharmaceutical manufacturers prepare to begin clinical testing of their new products. We ensure the safety of patients in clinical trials and provide advice to manufacturers on the design and conduct of the trial and the analysis of the trial results.
Vision
As regulatory scientists, we are safeguarding and advancing the health of the American people by ensuring that the FDA laws and regulations concerning new drug development, marketing applications, and expanded access programs, are followed, to facilitate the ongoing availability of new drugs that are safe and effective for their intended use and meet established quality standards.
What We Do
Ensure that safe and effective drugs and biologics are available to the American people. OND’s role is twofold: review applications and make an approval decision; set guidance and policy to ensure an efficient review process. OND reviews drug applications, interacts with the pharmaceutical industry and ultimately decides whether the benefits of a drug outweigh the known risks.