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 […]
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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
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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
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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
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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
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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,
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A 2002 report released by the Institute of Medicine concluded that there is “overwhelming evidence” that disparities in cancer treatment exist in the United States. According to the U.S. Department of Health and Human Services, health disparities can be defined as “differences in the occurrence, frequency, death and burden of diseases and other unfavorable health
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In Roanoke, Virginia, a time capsule buried beneath the floor at the Roanoke City Health Department office has officials stymied. The time capsule was originally scheduled to be exposed Thursday, January 7. That was until Virginia Department of Health officials discovered that the capsule was concealed beneath post-1950s flooring that likely contains asbestos. The asbestos
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Quebec health officials recently sent a letter to Canada’s federal Health Minister, Leona Aglukkaq, calling for an end to the government’s support of asbestos mining in the country. Within the letter, which was penned and backed by members of Canadian Association of Physicians for the Environment and Rideau Institute, health officials make known their concern
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