#FASTTRACK SCHEDULE VERSION 4 FOR SALE TRIAL#
In certain cases, especially if the disease is rare and multiple trials may not be feasible, convincing evidence from one clinical trial may be enough. Generally, the agency expects that the drug maker will submit results from two well-designed clinical trials, to be sure that the findings from the first trial are not the result of chance or bias. Assessment of benefits and risks from clinical data-FDA reviewers evaluate clinical benefit and risk information submitted by the drug maker, taking into account any uncertainties that may result from imperfect or incomplete data.For example, a drug intended to treat patients with a life-threatening disease for which no other therapy exists may be considered to have benefits that outweigh the risks even if those risks would be considered unacceptable for a condition that is not life threatening. Analysis of the target condition and available treatments-FDA reviewers analyze the condition or illness for which the drug is intended and evaluate the current treatment landscape, which provide the context for weighing the drug’s risks and benefits.The drug approval process takes place within a structured framework that includes: FDA Approval: What it meansįDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.
#FASTTRACK SCHEDULE VERSION 4 FOR SALE SERIES#
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.įor more information about the drug development and approval process, see How Drugs Are Developed and Approved.
The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.īefore 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.
If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. 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.ĭrug companies seeking to sell a drug in the United States must first test it. The main consumer watchdog in this system is FDA's Center for Drug Evaluation and Research (CDER). American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world.
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