What's CDER?

The primary responsibility of the Food and Drug Administration (FDA) is to enforce the Federal Food Drug and Cosmetics Act (FD&C). FDA is a large organization, at the top level FDA is divided into 6 primary centers and numerous offices. Here I will briefly discuss CDER, one of the more visible and influential centers within FDA.

CDER’s Responsibilities ¶

CDER is the Center for Drug Evaluation and Research. CDER’s stated mission is “to ensure that safe, effective and high-quality drugs are available to the public”. CDER’s regulatory responsibilities include¹:

• Prescription drugs
• Generics
• Over the counter drugs
• Biosimilars (generic biologics)
• Select therapeutic biologics

While most biologics²³ (such as vaccines and gene therapies) are overseen by the Center for Biologics Evaluation and Research (CBER), in 2003 FDA transferred the responsibility for regulating some therapeutic biologics to CDER⁴, including:

• Monoclonal antibodies
• Therapeutic proteins (interferons, enzymes etc.)
• Immunomodulators
• Growth factors

CDER Leadership and Staff ¶

CDER is led by Patrizia Cavazzoni, MD since 2020 (acting director 2020, director since 2021). Dr. Cavazzoni’s medical background is psychiatry and she spent a portion of her career working at various pharmaceutical companies ⁵.

CDER is a large FDA center, employing over 6,486 full time federal staff with a budget of $2.1Billion for FY25⁶

Offices within CDER ¶

CDER itself is divided into 13 Offices, including the Office of New Drugs and the Office of Generic Drugs.

The Office of New Drugs (OND) is led by Peter Stein, MD, who joined CDER in 2016 after serving as VP at both Merck and Janssen⁷. As the name implies, OND handles the approval process for new drugs applications (NDA) and the regulatory and scientific requirements surrounding that. OND also maintains Drugs@FDA, an important database with information about FDA-approved drugs that we use in our research.

The Office of Generic Drugs (OGD) is led by Iilun Murphy, MD, who has been with FDA since 2007⁸. OGD reviews applications for abbreviated new drug applications (ANDA’s)⁹, which are applications for generic drug approvals.

All told, CDER’s operations and guidance touch nearly every aspect of the pharmaceutical and life sciences industry. To stay up to date on notices and guidance from CDER, bookmark the FDA TRACK page for CDER. You’ll get updates on post-drug surveillance, policy, safety reviews and more.