We are taking steps to ensure that healthcare providers and patients are aware of the possible long-term risks of these products so that they will be used appropriately.
This new product will offer a much needed treatment option for patients suffering from this rare illness that, in some cases, has been found to progress to fatal forms of leukemia.
We're working to evaluate the potential risks and determine whether there is a need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients.
Before beginning any human trials, the sponsor must perform extensive animal toxicity studies. Animal studies provide guidance on initial dosing and point to areas of safety needing special attention during human studies.
Phase 2 studies are typically well controlled and closely monitored and may involve up to several hundred patients. At the conclusion of these studies, FDA (Food and Drug Administration) and the sponsor usually meet to determine how the drug's development should be studied in Phase 3 and how to design and conduct further trials.
This has the potential to improve the quality of life for millions of Americans with diabetes.
There are dangers to consumers who purchase diet pills that contain drugs of unknown origin and quality. These products are not approved by FDA and if people experience side effects, it is difficult to trace problems and for physicians to treat them.
Today's approval is a major step forward in making breakthrough treatments available for patients with rare and difficult-to-treat forms of cancer.
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