Final answer:
The FDA issued the interim rule for human tissue for transplantation in 1993. Additionally, the FDA has the authority to halt the development or use of gene therapy at all stages, including IND application, clinical trials, and after product marketing. Option b.
Step-by-step explanation:
The FDA issued the interim rule for human tissue for transplantation in the year 1993. This rule was developed to ensure the safe and effective use of human tissues for transplantation by establishing standards for donors and the transplantation process.
Regulation of Gene Therapy
In regards to when the FDA can halt the development or use of gene therapy, the correct answer is d. all of the answers are correct. The FDA has the authority to intervene at various stages: on submission of an IND application, during clinical trials, and after manufacturing and marketing of the approved therapy. This regulatory oversight ensures that gene therapies are properly evaluated for safety and efficacy throughout their development and use.