FDA regulation and application submission process for new drugs Term Paper

FDA regulation and application submission process for new doses - Term Paper Example down the stairsdeveloped a dose for wide use such as a summit cancer medicate binds a certain method. The development of any medication is test intensive. We send designate from these tests to prove the medicate is safe and effective. Experts will review our data. Once this independent review establishes the products health benefits outweigh the risks, the medicate whitethorn be approved. Before a drug can be tested in masses, we perform science laboratory and animal tests to investigate how it works and how likely it is to be safe. The human testing is conducted to investigate effectiveness. Orphan drug development is similar in some ship canal but different in others.To apply for deprive drug designation, we must complete a number of additional steps. First, we postulate to specify the unsoundness. Next, we must reach the appropriate documents including our figure and address, our c ontact person with title, address, and phone number as well as the name of the drug. Furthermore, we need to provide a description of the target disease, the indications for use of the drug, and the reasons why the drug is necessary to shroud the disease. We must provide specific scientific rationale including all data from cynical and nonclinical studies and additional sources lendable whether positive, negative, or inconclusive. Copies of pertinent unpublished and published papers be required. We must document how the disease affects fewer than 200,000 people in the United States. For a drug intended for a disease affecting 200,000 or more people, we must provide rationale why there would be no expectation that cost of research and development of the drug for the indication could be recovered by sales of the drug in the United States. ... tionale why there would be no expectation that costs of research and development of the drug for the indication could be recovered by sales o f the drug in the United States. In essence, we would follow all of the protocols of developing the drug for non-orphan status but with a few additional considerations.Questions remain as to why it might be prudent to develop the new drug as an orphan. First, there are certain government incentives to following this route. Government provides tax breaks, enhanced patent protection and marketing rights, as well as clinical research financial subsidization. Furthermore, it provides slightly relaxed statistical standards under the assumption that subjects with the disease in question may not be plentiful enough to derive a in truth large sample for testing. Still, there are ethical considerations. What if more people are helped otherwise We have a social responsibility to distribute a health benefiting drug to as many people who need it as possible. To develop under orphan drug protocol would limit the number breast cancer patients who might benefit from the drug. Although there are op erational and financial motivations for developing the drug under the orphan guidelines, they should not necessarily be the only considerations that play into our decision.Thinking on certain questions about(predicate) the prudence of following one drug development protocol versus another has been reported here. We have examined how ways to submit a drug application for a novel anticancer molecule showing evidence of efficacy in leiomyosarcoma. We briefly outlined the differences in approaches to develop this product. One approach is that of applying for orphan drug development. The other is that of developing the drug for breast cancer. We also explored certain