regulations of Fast Track
Discuss the process and regulations of Fast Track
Strict processes and regulations are considered are considered by the FDA before the approval of a drug. Moreover, the role of the manufacturing company is very important in that their compliance to ensure that their products and the conditions of their manufacture meet the minimum health requirements. According to Damle et al. (2016), the process and regulations under the provisions of FDA are defined by some aspects of eligibility. For instance, the company in question is required to have many frequent meetings the regulatory body which provides them the opportunity to discuss the development of a drug, and allow the collection of data for the support of approval. The manufacturing company is required to wait for many forms of written communication from the FDA regarding the standards like the design of proposed clinical trials (Damleet al., 2016). It will, therefore, be the role of the company to send the New Drug Application (NDA) to be reviewed by FDA and the eligibility may be confirmed if the criterion utilized is relevant to the stated standards.
Identify which medical conditions warrant the use of “Fast Track” drugs.
FDA has specific principles which must be met by the manufacturing company which occurs in the forms of medical conditions. On the same note, it is important to note that any newly developed drug is to prevent a condition without current therapy is normally directed at an unmet need. It is therefore expected that the drug in question presents some conditions which may comply with the available health standards (Damle et al., 2016). For example, FDA requires that a drug showing the superior effectiveness and improved effect on the unmet health conditions. Moreover, the regulatory body provides that a drug that is newly developed should be associated with minimum side effects to the users. Furthermore, a drug must address an anticipated or emerging public health need.
References
Damle, N., Shah, S., Nagraj, P., Tabrizi, P., Rodriguez, G., & Bhambri, R. (2016). FDA’s Expedited Programs and Their Impact on the Availability of New Therapies. Therapeutic Innovation & Regulatory Science, 51(1), 24-28. doi: 10.1177/2168479016666587
