Final answer:
Compounds become investigational new drugs (INDs) by undergoing development post-discovery, including toxicity testing and large-scale production designs. An IND application submitted to CDER starts the approval process, and after a 30-day review, clinical trials can initiate. Successful clinical trials lead to an NDA submission for FDA approval.
Step-by-step explanation:
After the initial discovery or synthesis of a drug, chemists engage in further developing the drug, which may include chemically altering it, testing its toxicity, and designing methods for large-scale production. Once a candidate drug has been identified, it undergoes significant laboratory data collection from animal trials before an Investigational New Drug (IND) application is submitted to the FDA's Center for Drug Evaluation and Research (CDER).
When the IND application is reviewed and accepted, a 30-day waiting period ensues, after which clinical trials involving human subjects may commence. The aim of these trials is to collect and analyze data concerning the drug's safety and effectiveness, as well as to monitor any side effects. Should any issues arise, the FDA has the authority to impose a “clinical hold” to address problems before or during the trials.
After successfully demonstrating the drug's efficacy and safety to the FDA's standards through the clinical trials, the development team may then submit a New Drug Application (NDA) for final approval before the drug can be marketed and made available to the public. This application includes comprehensive details about the drug's manufacturing, packaging, monitoring, and administration processes.