Final answer:
The IND applications for studies of marketed products are generally similar to those for new drugs, except that less preclinical data is required for marketed products. Nevertheless, information about the clinical trial design and safety monitoring is critical for both. Post-approval, a pharmacovigilance system continues to assess the long-term safety of new drugs.
Step-by-step explanation:
Content for an IND of Marketed Products vs. New Drugs
The content required for an Investigational New Drug (IND) application for studies of marketed products generally aligns with the content required for new drugs. However, there is an exception for marketed products. Since these drugs are already approved and their safety profile, pharmacokinetics, and pharmacodynamics are well-known, the IND submission may require less preclinical data. Nevertheless, the essential details related to the clinical trial design, methodologies, and safety monitoring plans remain crucial components of the submission.
For new drugs, the scrutiny is considerably more rigorous, starting with exhaustive laboratory data collected from animal trials followed by a thorough evaluation of the IND by the Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER). This is followed by a set of clinical trials mandated to establish both the effectiveness and safety of the drug before it can be deemed eligible for a New Drug Application (NDA). The NDA is comprehensive, documenting the manufacturing, packaging, monitoring, and administration aspects of the drug.
The process ensures any new therapy meets the standards for effectiveness and safety imposed by the FDA. It’s worth noting that once approved for marketing, drugs undergo continuous monitoring to assess long-term safety and the drug's effects on specific subgroups of patients. This is known as postmarket safety surveillance.