New drug development and approval process
The mission of FDA's Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. CDER does not test drugs, although the Center's Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness.
CDER is the largest of FDA's five centers. It has responsibility for both prescription and nonprescription or over-the-counter (OTC) drugs. For more information on CDER activities, including performance of drug reviews, post-marketing risk assessment, and other highlights, please see the CDER Update: Improving Public Health Through Human Drugs The other four FDA centers have responsibility for medical and radiological devices, food, and cosmetics, biologics, and veterinary drugs.
Some companies submit a new drug application (NDA) to introduce a new drug product into the U.S. Market. It is the responsibility of the company seeking to market a drug to test it and submit evidence that it is safe and effective. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the sponsor's NDA containing the data and proposed labeling.
The section below entitled From Fish to Pharmacies: The Story of a Drug's Development, illustrates how a drug sponsor can work with FDA's regulations and guidance information to bring a new drug to market under the NDA process.
Osteoporosis, a crippling disease marked by a wasting away of bone mass, affects as many as 2 million American, 80 percent of them women, at an expense of $13.8 billion a year, according to the National Osteoporosis Foundation., The disease may be responsible for 5 million fractures of the hip, wrist and spine in people over 50, the foundation says, and may cause 50, 000 deaths. Given the pervasiveness of osteoporosis and its cost to society, experts say it is crucial to have therapy alternatives if, for example, a patient can't tolerate estrogen, the first-line treatment.
Enter the salmon, which, like humans, produces a hormone called calcitonin that helps regulate calcium and decreases bone loss. For osteoporosis patients, taking salmon calcitonin, which is 30 times more potent than that secreted by the human thyroid gland, inhibits the activity of specialized bone cells called osteoclasts that absorb bone tissue. This enables bone to retain more bone mass.
Though the calcitonin in drugs is based chemically on salmon calcitonin, it is now made synthetically in the lab in a form that copies the molecular structure of the fish gland extract. Synthetic calcitonin offers a simpler, more economical way to create large quantities of the product.
FDA approved the first drug based on salmon calcitonin in an injectable. Since then, two more drugs, one injectable and one administered through a nasal spray were approved. An oral version of salmon calcitonin is in clinical trials now. Salmon calcitonin is approved only for postmenopausal women who cannot tolerate estrogen, or for whom estrogen is not an option.
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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.