The FDA will review the application and decide if the clinical trial can begin

The fda will review the application and decide if the

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The FDA will review the application and decide if the clinical trial can begin or be placed on a clinical hold. The FDA will contact the person in charge and inform them the study has a hold and that specific questions or concerns must be answered before the process can begin. The FDA should notify the sponsor within 30 days after the application is received if the process can begin. Scientific Advances The lack of money and grants often slows down scientific advancement in most disease cases. Advances in the cure for Huntington’s Disease remains the same, which is no cure. The goal is to relieve the symptoms associated with the disease in turn trying to improve the patient’s quality of life. Patients may be prescribed physical therapy to help improved their strengthening, cardiovascular exercises and stretching. According to Karcher, 2017 Tetrabenazine was approved for the treatment of hypokinesia and rigidity. Role of Family Taking care of a patient with HD while watching the family experience the decline of their mother, wife, sister and aunt. The need for increased care of the patient caused conflict between the family member roles. MM was involved with her children’s school as homeroom mother, school volunteer and President of the Parent Teacher Association. As the disease progressed she was unable to continue her involvement with the school activities or participate in the church as previously. The dynamics of the family were turned upside down and the husband was required to assume the roles the wife was previously responsible for as the disease progressed into the various stages. According to Frich et al, 2013 “partners and spouses
CASE REPORT PART II 4 experienced a loss of their equal partner and that the disease had brought a child into the family.” Instead of the parent protecting the child the youngest children often had to be protected from the uncontrolled behavior of the affected parent including inappropriate verbal comments.

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