Final answer:
Policies and procedures for investigational drugs should be developed by pharmaceutical companies and regulatory agencies like the FDA, to ensure drugs are safe and effective through extensive experimentation and trials.
Step-by-step explanation:
Written policies & procedures for investigational new drugs or controlled dangerous substances should be developed by organizations that conduct drug development and research, such as pharmaceutical companies, in conjunction with regulatory agencies like the Food and Drug Administration (FDA). These procedures are essential for ensuring that the investigational drugs are safe and effective for human use. This involves conducting large-scale experiments and clinical trials involving human subjects, which is a process that can take several years and requires the participation of various professionals including physicians, scientists, and chemists. Once the investigational drug meets the FDA's standards for safety and effectiveness, the developers can submit a New Drug Application (NDA), detailing the manufacturing, packaging, monitoring, and administration of the therapy.