Final answer:
The timeframe for submitting a permit for a new pharmacy is dependent on local regulations and is not covered by the FDA's drug approval process. Pharmacy permit applications are generally managed by local or regional health departments or pharmacy boards, who will provide the specific guidelines and necessary lead time before opening.
Step-by-step explanation:
The question, "An application for a permit for a new pharmacy should be submitted how long prior to opening of the pharmacy?" relates to the regulatory aspects of starting a new pharmacy. While the provided information speaks to the FDA approval process for a new therapy, the specific timeframe for submitting an application for a pharmacy permit can vary greatly by jurisdiction and is not explicitly covered in the FDA process for drug approvals. Generally, the timeframe will be stipulated by the relevant health department or pharmacy board of the region where the pharmacy will be opened.
In the context of the FDA drug approval process, an Investigational New Drug (IND) application is submitted and must pass a 30-day waiting period before clinical trials can begin. Following successful trials, a New Drug Application (NDA) is created and submitted for review. However, please note that these applications relate to the approval of drugs, not the opening of pharmacy premises.
It is recommended for anyone looking to establish a new pharmacy to consult the local regulations and requirements, which typically include completing an application process, securing a venue, fulfilling staffing requirements, and passing inspections, among other necessities. The local pharmacy board or similar entity will provide the specific guidelines, including the necessary lead time prior to opening a pharmacy.