In North Carolina, what must be provided by the pharmaceutical manufacturer before a medication can be sold?

In North Carolina, before a medication can be sold, it is essential for the pharmaceutical manufacturer to obtain a New Drug Application (NDA) approval from the Food and Drug Administration (FDA). The NDA process requires rigorous submission of data demonstrating the drug's safety, efficacy, and quality based on clinical trial results. This ensures that the medication has been thoroughly evaluated before it is made available to the public.

The approval of an NDA is a critical step as it allows the manufacturer to market the drug legally. It reflects compliance with federal regulations intended to protect public health by ensuring that new medications meet necessary benchmarks for safety and effectiveness. This regulatory framework is crucial for maintaining trust in the pharmaceutical market.

Other elements like marketing strategies, trial study reports, and pricing structures, while important for various business and operational functions, are not prerequisites for selling a medication in North Carolina. Regulatory approval is central to ensuring that only safe and effective medications reach consumers.