Question

Which of the following describes how the health of a newborn is affected by FDA regulations?

A. FDA regulations ensure that newborn formula is safe and nutritious.
B. FDA regulations ensure that newborn medical devices are safe and effective.
C. FDA regulations help to reduce the risk of foodborne illness in newborns.
D. All of the above

Answer 1

Newborn health is positively impacted by FDA regulations ensuring safety and efficacy of medicines and reducing exposure to harmful substances; however, stringent FDA processes can delay beneficial treatments. Gene therapy development can be halted by the FDA at various stages to prioritize safety.

Step-by-step explanation:

The health of a newborn is considerably influenced by FDA regulations which ensure that medicines and products intended for both pregnant women and newborns are rigorously tested for safety and efficacy. These regulations can mitigate potential risks associated with exposure to harmful industrial compounds that might affect the baby's development, such as brain and nervous system toxicity, which could be transmitted via the mother's use during pregnancy. For instance, FDA oversight may limit or prevent the prenatal transfer of harmful substances, protecting the immune system, reproductive systems, and overall development of the newborn.

However, the stringent testing and approval process can also mean delays in the availability of potentially beneficial medications or treatments. This could disadvantage individuals who might benefit from new therapies that are slow to reach the market. In the context of gene therapy, for instance, the FDA has the authority to halt development at various stages—including submission of an IND application, during clinical trials, or even after manufacturing has begun—if there are concerns about safety or efficacy.