Approved drug#Approval

In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition.{{Cite web|last=Commissioner|first=Office of the|date=2019-04-18|title=Understanding Unapproved Use of Approved Drugs "Off Label"|url=https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label|access-date=2021-04-21|website=FDA|language=en}} Drug companies seeking to sell a drug in the United States must first test it. The company then sends the Food and Drug Administration's Center for Drug Evaluation and Research (CDER){{Cite web|url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/default.htm|archive-url=https://web.archive.org/web/20111124153844/http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/default.htm|url-status=dead|archive-date=November 24, 2011|title=About the Center for Drug Evaluation and Research|last=Research|first=Center for Drug Evaluation and|website=www.fda.gov|language=en|access-date=2018-01-21}} evidence from these tests to prove the drug is safe and effective for its intended use. A fee is required to make such FDA submission. For financial year 2020, this fee was: for an application requiring clinical data ($2,942,965) and for an application not requiring clinical data ($1,471,483).{{cite web |title=Prescription Drug User Fee Rates for Fiscal Year 2020 |url=https://www.federalregister.gov/documents/2019/08/02/2019-16435/prescription-drug-user-fee-rates-for-fiscal-year-2020 |publisher=USA (Federal register) |access-date=9 August 2019}} A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.

As of the end of 2013, the FDA and its predecessors had approved 1,452 drugs, though not all are still available, and some have been withdrawn for safety reasons.[https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2014/10/how-many-drugs-has-fda-approved-in-its-entire-history-new-paper-explains How Many Drugs has FDA Approved in its Entire History? New Paper Explains] Accounting for subsequent corporate acquisitions, these approvals were earned by approximately 100 different organizations.

In the European Union, it is the European Medicines Agency (EMA) that evaluates medicinal products.

In Japan, the agency regulating medicinal products is Pharmaceuticals and Medical Devices Agency (PMDA).

On average, only one in every 5,000 compounds that makes it through lead development to the stage of preclinical development becomes an approved drug. Only 10% of all drugs started in human clinical trials become an approved drug.{{cite news |author=Ezekiel J. Emanuel |title=The Solution to Drug Prices |url=https://www.nytimes.com/2015/09/09/opinion/the-solution-to-drug-prices.html?_r=0 |quote=On average, only one in every 5,000 compounds that drug companies discover and put through preclinical testing becomes an approved drug. Of the drugs started in clinical trials on humans, only 10 percent secure F.D.A. approval. ... |newspaper=The New York Times |date=9 September 2015 |author-link=Ezekiel J. Emanuel }}{{cite journal| last=Wong | first=Chi Heem | last2=Siah | first2=Kien Wei | last3=Lo | first3=Andrew W | title=Estimation of clinical trial success rates and related parameters | journal=Biostatistics | volume=20 | issue=2 | date=31 January 2018 | issn=1465-4644 | doi=10.1093/biostatistics/kxx069 | pmid=29394327 | pmc=6409418 | pages=273–286}}{{cite web | last=Lowe | first=Derek | title=A New Look at Clinical Success Rates | publisher=In the Pipeline, American Association for the Advancement of Science | date=2 February 2018 | url=https://blogs.sciencemag.org/pipeline/archives/2018/02/02/a-new-look-at-clinical-success-rates | access-date=4 May 2019}}

• Drug discovery
• Drug design
• Drug development
• Abbreviated New Drug Application
• Patent medicine

{{reflist}}

• [http://www.clinicaltrials.gov/ ClinicalTrials.gov] from US National Library of Medicine
• [http://www.ich.org ICH Website]
• [https://archive.today/19961018195855/http://www.fda.gov/ FDA Website]
• [https://commons.wikimedia.org/wiki/File:Simple_Steps_for_Using_Medications_Safely.png Simple Steps for Using Medications Safely by FDA]

Category:Clinical research

Category:Drug development