Final answer:
The answer is true; an FDA approved drug must have a National Drug Code (NDC). The NDC serves as a unique identifier for the drug, while the FDA ensures the safety and efficacy of medicines, benefitting patients, but potentially disadvantaging pharmaceutical companies and patients waiting for new treatments due to the lengthy approval process.
Step-by-step explanation:
True. Any drug that has been approved by the FDA must have an NDC, which is a unique identifier that denotes the specifics of the product including the labeler, product, and commercial package size. The New Drug Application (NDA) is a rigorous process through which drugs receive FDA approval, and it ensures the drug is "safe and effective" when used according to its labeling.
When it comes to the regulation of medicines, strict medical regulations have their winners and losers. Patients benefit by being protected from unsafe drugs, while the more anonymous losers are often the pharmaceutical companies which incur substantial costs and delays due to the lengthy process of drug testing and approval. Moreover, patients with urgent needs may also suffer if the availability of potentially life-saving drugs is delayed. The FDA oversees the entire process, from initial lab and animal studies in the IND phase to clinical trials and eventually the submission and approval of an NDA.