Final answer:
The FDA can stop an IND at any point during the drug development process, including before or during clinical trials and even after the drug has been approved and marketed, if necessary to ensure patient safety.
Step-by-step explanation:
When Can the FDA Stop an IND?
The FDA can halt an Investigational New Drug (IND) at various points in the drug development process. The FDA may order a “clinical hold” on an IND if there are concerns about patient safety or other significant issues either prior to or during the clinical trials. Once clinical trials are underway, the FDA continues to monitor the safety and effectiveness of the therapy. Should serious problems arise, the FDA has the authority to pause or stop the trials. Moreover, even after a New Drug Application (NDA) approval, the drug's safety continues to be monitored through adverse event reporting, with the FDA having the power to require additional postmarketing studies or impose restrictions if new safety concerns are identified. Adverse events must be reported to the FDA, with serious and fatal events requiring expedited reporting within 15 days, and other events on a quarterly basis.
To answer the multiple-choice question directly, the options a (on submission of an IND application), b (during clinical trials), and c (after manufacturing and marketing of the approved therapy) are correct, which makes d (all of the answers are correct) the correct answer. The FDA may halt the development or use of gene therapy at any of these stages if it deems it necessary to protect patient safety or address any other significant concerns.