The Pharmaceutical Industry And Health Professional Services
My strategy as a health care administrator communicating with Get Well Drugs is to evaluate new drugs before they can be sold. Center for Drug Evaluation and Research (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. First, I will test the drug to make sure it 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 will not actually test the drugs, 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. Clinical trials are experiments that use human subjects to see whether a drug is effective, and what side effects it may cause.
New drugs, like other new products, are frequently under patent protection during development. When the patents or other periods of exclusivity on brand-name drugs expire, manufacturers can apply to the FDA to sell generic versions. If FDA finds a problem, it can order a”clinical hold" to delay an investigation, or interrupt a clinical trial if problems occur during the study. I would ask questions directed toward Get Well drugs such as; Does the FDA require that animals of both sexes be included in non-clinical studies? The difference between
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. Clinical trials are experiments that use human subjects to see whether a drug is effective, and what side effects it may cause.
New drugs, like other new products, are frequently under patent protection during development. When the patents or other periods of exclusivity on brand-name drugs expire, manufacturers can apply to the FDA to sell generic versions. If FDA finds a problem, it can order a”clinical hold" to delay an investigation, or interrupt a clinical trial if problems occur during the study. I would ask questions directed toward Get Well drugs such as; Does the FDA require that animals of both sexes be included in non-clinical studies? The difference between