New drug Development, FDA
American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA's Center for Drug Evaluation and Research (CDER).
The center's best-known job is to evaluate new drugs before they can be sold. CDER's evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.
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.
You might also like
FDA drug approval at lowest rateby china_blue
Since Vioxx withdrawal, only 37 treatments received federal OK
Thursday, January 04, 2007
BY GEORGE E. JORDAN
As the American pharmaceutical industry grapples with layoffs and spending cuts, newly released statistics show drugmakers continue to struggle with the discovery of blockbuster medicines.
The Food and Drug Administration approved only 17 new drugs last year, matching the lowest number of newly approved compounds since the peak of 53 approvals a decade ago...
Fda sets level for poison in baby food:by bornagaingumby
WASHINGTON Two months ago, federal food regulators said they were unable to set a safety threshold for the industrial chemical melamine in baby formula. Now, however, they found a way to settle on a standard that allows for higher levels than those found in U.S.-made batches of the product.
Food and Drug Administration officials on Friday set a threshold of 1 part per million of melamine in formula, provided a related chemical is not present. They insisted the formulas are safe.
The development comes days after The Associated Press reported that FDA tests found traces of melamine in the infant formula of one major U
Polyamine transport in parasites: A potential target for new antiparasitic drug development [An article from: Comparative Biochemistry and Physiology, Part C]
Inform Genomics and Translational Drug Development (TD2) Announce .. — MarketWatch
.. LLC (TD2) based in Scottsdale, Arizona, today announced a strategic collaboration leveraging Inform Genomics' proprietary technology platform and analytic capabilities to biopharmaceutical companies through TD2's oncology drug development services.
Medical innovation prize fund: new idea in drug development.: An article from: AIDS Treatment News
Book (John S. James)
Technological foresight-the use of biotechnology in the development of new drugs against breast cancer [An article from: Technovation]
Africa's first narco-state: it's hard to believe, but Guinea-Bissau was once hailed as a potential model for African development.(The Big Story: ILLEGAL DRUGS): An article from: New Internationalist
Book (New Internationalist Magazine)
Current Developments in Monetary and Financial Law, Vol. 5
eBooks (INTERNATIONAL MONETARY FUND)