Final answer:
The specific number of days the FDA has to act on a completed NDA is not stated in the provided information. Nonetheless, post-approval, serious and fatal adverse drug experiences must be reported to the FDA within 15 days, with the NDA submission being a detailed step involving data from extensive trials.
Step-by-step explanation:
Under the regulations of the Food and Drug Administration (FDA), once a New Drug Application (NDA) is submitted, the FDA has specific timelines to adhere to. The key statute managing these timelines is the Food, Drug, and Cosmetic Act, which has been updated by various amendments, including the significant Food and Drug Administration Amendments Act (FDAAA) of 2007. However, the exact number of days the FDA has to act on a completed NDA is not provided within the text available. It is essential to note that after approval, the sponsor must report any patient adverse drug experience to the FDA with serious and fatal adverse drug events reported within 15 days.
The NDA is a critical step in the process of getting a new therapy to market, where researchers submit significant data from both laboratory and clinical trials. The NDA details how the therapy will be manufactured, packaged, monitored, and administered. This data is reviewed thoroughly, ensuring that the new therapy meets standards for effectiveness and safety, prior to FDA approval.