Final answer:
The subject query pertains to the form FDA blank, which is about the process of submitting an Investigational New Drug (IND) application, a precursor to the New Drug Application (NDA) for drug approval by the FDA. Clinical holds can be issued by the FDA to address any concerns during the drug approval process. Generic drugs, after the patent of the original drugs expire, can be approved through an ANDA if shown to be therapeutically equivalent.
Step-by-step explanation:
The student's question asks about the form associated with the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The IND application is a critical step in the process of getting approval for a new drug. A clinical hold may be ordered by the FDA if any problems are identified either prior to or during the clinical trials to ensure safety and effectiveness.
Once the clinical trial phase is complete and the drug is deemed both safe and effective, the drug developers then submit a New Drug Application (NDA). This document details the manufacturing, packaging, monitoring, and administration methods for the new therapy. For generic drugs, a simpler Abbreviated New Drug Application (ANDA) can be submitted once the original drug's patent has expired, provided the generic is shown to be therapeutically equivalent to the branded drug.