Center for Drug Evaluation and Research

Edit links
Source: Wikipedia, the free encyclopedia.
Regulation of therapeutic goods in the United States
Prescription drugs
Over-the-counter drugs
Law
Government agencies
Process
International coordination
Non-governmental organizations
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

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[

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]

The FDA's budget for approving, labeling, and monitoring drugs is roughly $290 million per year[citation needed]. 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].

Patrizia Cavazzoni is the current director of CDER.[1]

Responsibilities

CDER reviews

over-the-counter
(OTC) medications are safe and effective when used as directed.

The FDA requires a four-phased series of

clinical trials
for testing drugs. Phase I involves testing new drugs on healthy volunteers in small groups to determine the maximum safe dosage. Phase II trials involve patients with the condition the drug is intended to treat to test for safety and minimal efficacy in a somewhat larger group of people. Phase III trials involve one to five thousand patients to determine whether the drug is effective in treating the condition it is intended to be used for. After this stage, a new drug application is submitted. If the drug is approved, stage IV trials are conducted after marketing to ensure there are no adverse effects or long-term effects of the drug that were not previously discovered.

With the rapid advancement of biologically-derived treatments, the FDA has stated that it is working to modernize the process of approval for new drugs. In 2017, Commissioner Scott Gottlieb estimated that they have more than 600 active applications for gene and cell-based therapies.[2]

Divisions

CDER is divided into 8 sections with different responsibilities:[3][4]

  • Office of New Drugs
This office is responsible for oversight of clinical trials and other studies during drug development, and for the evaluation of new drug applications
The Office of New Drugs is divided into several departments based on the indication of the drug (the medical need for which it is being proposed)
  • Office of Generic Drugs
This office reviews generic drug applications to ensure generic drugs are equivalent to their branded forms
  • Office of Strategic Programs
This office is responsible for business programs, represents CDER in the FDA Bioinformatics Board, and communicates with other agencies
  • Office of Pharmaceutical Quality
This office is responsible for integrating assessment, inspection, surveillance, policy, and research activities to strengthen pharmaceutical quality on a global scale.
  • Office of Surveillance and Epidemiology
This office is responsible for post-marketing surveillance to identify adverse effects that may not have been apparent during clinical trials, using the MedWatch program
  • Office of Translational Sciences
This office promotes collaboration across offices in CDER by maintaining databases and biostatistical tools for evaluating drugs
  • Office of Medical and Regulatory Policy
This office develops and reviews guidelines pertinent to CDER's mission of ensuring the safety of drugs
  • Office of Compliance
This office ensures compliance with regulations relating to drug development and marketing

History

The FDA has had the responsibility of reviewing drugs since the passage of the 1906

Federal Food, Drug and Cosmetic Act required all new drugs to be tested before marketing by submitting the original form of the new drug application. Within the first year, the FDA's Drug Division, the predecessor to CDER, received over 1200 applications. The Drug Amendments of 1962 required manufacturers to prove to the FDA that the drug in question was both safe and effective. In 1966, the division was reorganized to create the Office of New Drugs, which was responsible for reviewing new drug applications and clinical testing of drugs.[5]

In 1982, when the beginning of the

Center for Devices and Radiological Health
.

In 1987, under Commissioner

tissue plasminogen activator) led to the split.[6]

In its original form, CDER was composed of six offices: Management, Compliance, Drug Standards, Drug Evaluation I, Drug Evaluation II, Epidemiology and Biostatistics, and Research Resources. The Division of Antiviral Products was added in 1989 under Drug Evaluation II due to the large amount of drugs proposed for treating AIDS.[5] The Office of Generic Drugs was also formed.

In 2002, the FDA transferred a number of biologically produced therapeutics to CDER.

growth factors and other products designed to alter production of blood cells.[7]

References

  1. ^ "CDER Leadership Bios". FDA. 22 December 2022. Retrieved 24 December 2022.
  2. ^ Burton, Thomas M. (7 September 2017). "FDA Modernizing Evaluations as Gene, Cell Therapy Fields Grow". Wall Street Journal – via www.wsj.com.
  3. ^ "Archived copy" (PDF). Food and Drug Administration. Archived from the original (PDF) on 2017-01-13. Retrieved 2017-02-01.{{cite web}}: CS1 maint: archived copy as title (link)
  4. ^ Research, Center for Drug Evaluation and (3 March 2022). "About the Center for Drug Evaluation and Research - CDER Offices and Divisions". www.fda.gov.
  5. ^ a b "A Brief History of the Center for Drug Evaluation and Research". US FDA. Retrieved 1 February 2017.
  6. ^ a b c d e f Reid, Ken. "CBER and CDER have long history of being lumped together and split up." Bioresearch Monitoring Alert Sept. 2002. page 4.
  7. ^ Research, Center for Drug Evaluation and (2 November 2021). "About the Center for Drug Evaluation and Research - Drug Application and Approval Process -". www.fda.gov.

External links

Retrieved from "https://en.wikipedia.org/w/index.php?title=Center_for_Drug_Evaluation_and_Research&oldid=1143795600"