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2015 SESSION

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HB 2050 Investigational drugs, biological products, and devices; expanded access.

Introduced by: Mark D. Sickles | all patrons    ...    notes | add to my profiles

SUMMARY AS INTRODUCED:

Expanded access to investigational drugs, biological products, and devices. Provides that a manufacturer of an investigational drug, biological product, or device may make such drug, product, or device available to a person who has a terminal illness when (i) the person has a terminal condition; (ii) the person has, in consultation with his physician, considered all other treatment options currently approved by the U.S. Food and Drug Administration; (iii) the person's physician has recommended treatment with an investigational drug, biological product, or device; and (iv) the person has provided written informed consent. The bill provides that a manufacturer that provides such drug, product, or device may provide it free of charge or may require the person to pay costs associated with its manufacture.


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