View source for Center for Drug Evaluation and Research

{{Organization
|OrganizationName=Center for Drug Evaluation and Research
|OrganizationType=Independent Agencies (Sub-organization)
|Mission=The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of people in the United States. CDER evaluates new drugs before they can be sold, monitors drug safety, and provides accurate, science-based drug information to the public.
|ParentOrganization=Food and Drug Administration
|TopOrganization=Department of Health and Human Services
|Employees=4500
|OrganizationExecutive=Director
|Services=Drug approval; Drug safety monitoring; Drug development guidance; Educational outreach; Post-market surveillance
|Regulations=21 CFR Parts 300-499 (Drugs for Human Use)
|HeadquartersLocation=39.02886, -76.98316
|HeadquartersAddress=10903 New Hampshire Ave, Silver Spring, MD 20993
|Website=https://www.fda.gov/drugs
}}
{{Short description|US Food and Drug Administration division}}

{{Regulation of therapeutic goods in the United States}}
[[File:FDA Bldg 51 - Main Entrance (5161374834).jpg|thumb|FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research.]]
The '''Center for Drug Evaluation and Research''' ('''CDER''', pronounced "see'-der") is a division of the [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA) that monitors most drugs as defined in the [[Food, Drug, and Cosmetic Act]].  Some biological products are also legally considered drugs, but they are covered by the [[Center for Biologics Evaluation and Research]].  The center reviews applications for brand name, generic, and over the counter pharmaceuticals, manages US [[current Good Manufacturing Practice]] (cGMP) regulations for pharmaceutical manufacturing, determines which medications require a [[medical prescription]], monitors advertising of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on the market.

CDER receives considerable public scrutiny, and thus implements processes that tend toward objectivity and tend to isolate decisions from being attributed to specific individuals. The decisions on approval will often make or break a small company's stock price{{citation needed|date=November 2014}} (e.g., [[Martha Stewart]] and [[Imclone]]), so the markets closely watch CDER's decisions.

The center has around 1,300 employees in "review teams" that evaluate and approve new drugs. Additionally, the CDER employs a "safety team" with 72 employees to determine whether new drugs are unsafe or present risks not disclosed in the product's labeling.{{citation needed|date=February 2017}}

The FDA's budget for approving, labeling, and monitoring drugs is roughly $290 million per year{{citation needed|date=November 2014}}. The safety team monitors the effects of more than 3,000 prescription drugs on 200 million people with a budget of about $15 million a year{{citation needed|date=November 2014}}.

[[Patrizia Cavazzoni]] is the current director of CDER.<ref name="CDER bios">{{cite web |title=CDER Leadership Bios |url=https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-leadership-bios |website=FDA |access-date=24 December 2022 |language=en |date=22 December 2022}}</ref>