The United States Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. The FDA is known for its work in regulating the development of new drugs. The FDA has developed rules regarding the clinical trials that must be done on all new medications. Pharmaceutical companies must test drugs through four phases of clinical trials before they can be marketed to individuals.
FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions. The agency is separated into divisions that oversee a majority of the organization’s obligations involving food, drugs, cosmetics, animal food, dietary supplements, medical devices, biological goods, and blood products.
What Does FDA Approved Mean?
FDA approval of a drug means that data on the drug’s effects have been reviewed by FDA’s Center for Drug Evaluation and Research (CDER) and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.
Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. 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.
Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it’s likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.
Why FDA approvals are important
Apart from the fact that FDA approval guarantees safety, companies that are focused on the development and sale of new drugs can be left without key products to drive their revenue if their products fail to receive approvals. The influence the FDA wields regarding drug testing can affect the stock market. The release of test data might be seen by investors as a measure for future growth for companies that manufacture and market drugs.
How do you check if a company is registered with FDA?
Releasable establishment registration and listing information under the Freedom of Information Act is available by searching the Establishment Registration and Listing database. The database is updated weekly, usually every Monday. To search: Enter information in one or more boxes (fields) and select the search button.
How to find out if a drug is approved
To find out if a drug is approved by FDA, consumers can use two different Internet sites:
- Drugs@FDA lists most prescription and over-the-counter (OTC) drug products approved since 1939. Drugs@FDA helps consumers find generic equivalents and other possible appropriate alternatives to their approved products as well as the product’s drug label. FDA updates this list every day.
- The FDA “Orange Book” contains drugs approved by FDA under New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). This site is regularly updated and shows the date of the most current update at the top of the page.
If consumers would like more information, they can call 301-827-4573 or 888-INFO-FDA (1-888-463-6332). Questions can also be submitted by e-mail to druginfo@fda.hhs.gov.
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