Exploration of expanded access (compassionate use) of investigational products

refer to ″Readings″ from the Assignment Instruction and from the attached files to answer the following assignment questions (also included in the instruction): In
light of the “FDA requirements” and your readings about “advocacy groups”, consider the following 3 questions: • Should the public have a right to investigational
treatment outside expanded access, defend your choice? • What are the implications of expanded access on drug development from the pharma and FDA perspective? • Are
the FDA regulations and guidance in place for expanded access sufficient in both protecting the public’s safety and also addressing the ethical concern of allowing
patients with severe or life-threatening diseases the option to have access to an investigational product where the benefits and risks are still being explored?