Final answer:
The FDA adheres to the Code of Federal Regulations (CFR), which includes rules for companies in the production of food, drugs, and other items. IRBs ensure compliance with federal guidelines for human studies, and IACUCs oversee animal research ethics as per NIH guidelines.
Step-by-step explanation:
Regarding the application of standards and laws by the FDA, the correct answer would be B- The Code of Federal Regulations. The FDA operates under the Code of Federal Regulations (CFR), which outlines the rules and procedures for domestic and foreign companies involved in the production of food, pharmaceuticals, cosmetics, and medical devices in the United States. Institutional Review Boards (IRBs) ensure that studies involving human subjects follow proper guidelines to protect participants, as mandated by federal regulations overseen by the U.S. Department of Health and Human Services. While local requirements, as well as guidelines created by international consensus such as those from the International Council for Harmonisation (ICH), can influence FDA recommendations, the direct legal framework the FDA adheres to is the CFR. Additionally, it is worth noting that when research uses animals, the facilities must have an Institutional Animal Care and Use Committee (IACUC) as per National Institutes of Health (NIH) guidelines to oversee the ethical treatment of animals.