Final answer:
The FDA reviews Investigational New Drug (IND) submissions within a 30-day waiting period. This ensures safety and efficacy before clinical trials. If any concerns arise, trials can be paused until resolved, and after approval, adverse events must be reported promptly to the FDA.
Step-by-step explanation:
The FDA has a set amount of time to review an Investigational New Drug (IND) submission. After researchers collect laboratory data from animal trials and submit an IND application to the FDA's Center for Drug Evaluation and Research (CDER), the FDA has a 30-day waiting period to review the IND before clinical trials involving human subjects can commence. This is a critical step in ensuring the safety and efficacy of potential new therapies before they are tested in humans.
Following this review, if the FDA identifies any issues, they can place the application on a "clinical hold" until these are resolved. During clinical trials, the IND sponsors are responsible for collecting and analyzing data concerning the therapy's safety and side effects. If the clinical trials indicate that the therapy is safe and effective, the developers may then proceed to submit a New Drug Application (NDA), which encompasses manufacturing, packaging, surveillance, and administration details of the therapy for final approval.
It is also important to note that after NDA approval, the sponsor must report all serious and fatal adverse drug events to the FDA within 15 days. In addition, they must report other adverse drug events quarterly. Adverse event reports are also received through the FDA's MedWatch program, which relies on voluntary reporting from consumers and health professionals.
Finally, the FDA has the authority to halt the development or usage of a therapy at various stages, including upon IND submission, during clinical trials, or after manufacturing and marketing if the approved therapy poses significant risks.