Final answer:
A drug may require prior authorization by a healthcare plan before a member can receive it. The FDA's rigorous approval process involves continuous monitoring for safety through a pharmacovigilance system and various postmarket studies and trials. An acceptable risk assessment must be completed to confirm a drug's safety and efficacy for human use.
Step-by-step explanation:
A drug may require a type of approval known as prior authorization by the plan before a member can receive it. This is a process where a drug must be approved by a patient's healthcare plan before being dispensed. Even after receiving marketing approval, a drug must be continuously monitored through an appropriate pharmacovigilance system to evaluate its long-term safety and effects in specific patient subgroups.
The Food and Drug Administration (FDA) plays a crucial role in the drug approval process. Drugs, especially new molecular entities, undergo rigorous scrutiny during the New Drug Application (NDA) process. New drugs are by default available only by prescription, and a switch to over-the-counter status requires separate approval. Postmarket safety surveillance includes FDA requirements for Phase IV trials and potential risk management plans, ensuring continuous monitoring and evaluation for safety.
To determine whether a drug is suitable for human administration, an acceptable risk assessment must be conducted. This involves extensive experiments and clinical trials to ensure that the drug is safe and effective. It takes several years of testing and data collection involving physicians and scientists to obtain FDA approval.