id	author	title	date	pages	extension	mime	words	sentence	flesch	summary	cache	txt
ihlr-22950	Termini, Roseann B.	The Latest "Federal Movement" in the Food and Drug Law Arena: The Federal Right-to-Try or Rather Right-to-Know and Thus Request Investigational Therapies for Individuals with a Life-Threatening Disease or Condition	2019	31	.pdf	application/pdf	11788	597	49	However, according to the Goldwater Institute, in the last few years, approximately 41 states have enacted legislation that addresses investigational drug access by the terminally ill.14 These states include: Alabama, Alaska, Arizona, Arkansas, California, 4. FDA has the authority to exempt investigational use devices from particular requirements that other devices must abide by.66 An approved IDE application permits shipment of a device, otherwise subject to marketing clearance.67 An approved IDE permits use in a clinical trial to gather safety and efficacy data necessary to substantiate some 510(k) submissions and for PMA’s.68 Clinical studies are a requisite for a PMA and in some instances a 510(k) and require: an approved IDE by an institutional review board (IRB); informed consent from patients; labeling that details investigational use only; and records and reports.69 VI.	cache/ihlr-22950.pdf	txt/ihlr-22950.txt