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Off-label use An FDA approval implies that the drug can now be used to treat a specific condition when it is administered in the manner described on the drug’s label. Further clinical research may be required to study other potential uses of the drug, for example, to treat a different form of cancer. An off-label [...]
Orphan drugs Drugs that are used to treat rare diseases affecting less than 200,000 Americans are referred to as orphan drugs. Since only a small number of patients need these drugs, it may not be possible for the drug’s sponsor to recover the drug development costs. Under the Orphan Drug Act, sponsors are given incentives [...]
Patient can contribute to the drug development and approval process by enrolling themselves in clinical trials. Participating in clinical trials not only contributes to improvements in cancer research and treatment but also allows enrolled patients access to closely monitored care and regular reviews on the status of their disease. The FDA has launched two programs [...]
1) Accelerated approval The accelerated approval program run by FDA allows sponsors to request approval on the basis of alternate findings. Also called surrogate endpoints, these are indirect assessments of disease status, for example, a change in lab results or improvements in symptoms related to the disease. These endpoints can also be used to assess [...]
Way back in the 1920s, a German scientist by the name of Otto Warburg reported to the world that cancer cells metabolize sugars in different ways than normal healthy cells. While such a discovery may not seem particularly momentous, this near century-old discovery is continuing to prove its importance by opening the door to a [...]
With its fast track drug development programs, the FDA seeks to facilitate the development of new drugs and speed up their approval process. This is especially true in case of drugs that can provide for unmet medical needs pertaining to debilitating or life-threatening diseases such as cancer. An unmet medical need is said to exist [...]
The drug regulatory agency in every country has its own specific requirements for drug approval. A drug that has received approval in Japan or Europe cannot be sold in the U.S. market until it gets approved by the Food and Drug Administration. The creation of the International Conference on Harmonization (ICH) was part of the [...]
Road workers in Florida are still finding masses of dangerous asbestos at a highway construction site near Fort Myers. Work crews employed by Lee County to look into the site near Summerlin Road came across three pieces of the dangerous substance on the site’s east side. They also exposed asbestos-laced concrete chunks that had been [...]
In December, President Obama signed a defense-funding bill that would allot $3.2 million to clean up and reclaim land around California’s Mount Umunhum near San Francisco. The area previously hosted Almaden Air Force Station from 1957 to 1980, a site that was home to many operations that left toxic wastes in the water and soil, [...]
