The Office Of New Drugs (OND), CDER, FDA

Me and some of my FDA Co-Workers, Silver Spring, MD 1991

This is Part 2 of the series on Federal Agencies that have touched my personal life. Part 1 that I briefly discussed the other day was the Bureau of Census(BofC), Department of Commerce.  The BofC just appointed Ditas my youngest daughter as Associate Director for Communications.    https://usa.inquirer.net/98432/fil-am-appointed-to-a-top-u-s-census-bureau-post

This posting is about the Office of New Drugs (OND) and the Division of Anti-Infective Drug Products. I was with the Anti-Infective Drugs Products for 12 years from 1990 to 2002. I started as a Review Chemist and retired as a Chemistry Team Leader. The 12 years of my professional life with the FDA was the happiest, most productive, most challenging and rewarding job in my professional career.    

https://davidbkatague.blogspot.com/2021/07/our-fda-years-1990-2002-for-storyworth.html

For Details visit this site:

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-offices-and-divisions

The Office of New Drugs (OND) ensures that safe and effective drugs and biologics are available to the American people. OND includes eight review offices with 27 review divisions. 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.

What We Do:

• Provide regulatory oversight for investigational studies during drug development.
• Make decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products.
• Provide guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.
• Communicate with the pharmaceutical industry to achieve the common goal of more efficient drug development.
• Oversee the 21st Century Review initiative, which is a set of performance standards CDER follows when conducting drug reviews. The goal of this initiative is to make the drug review process organized and integrated, and ensure all decision makers are heard.
• Update and maintain the Drugs@FDA database, which contains information about FDA-approved brand name and generic prescription and over-the-counter (OTC) human drugs and biological therapeutic products. The database includes most of the drug products approved since 1939.
• Maintain and update information about current drug shortages, and answers frequently asked questions about drug shortages.
• Maintain a searchable database of post-market studies and clinical trials for drugs and biological products.
• Regulate OTC drugs.
• Regulate drug labeling for human prescription drugs to ensure they contain essential scientific information needed for the safe and effective use of the drug.

 Here are more pictures of my FDA years

Here's the organizational chart for the Office of New Drugs

https://www.outsourcedpharma.com/doc/reorganization-office-new-drugs-corresponding-changes-translational-sciences-pharmaceutical-quality-0001