FDA Issues Final Rules to Assist Patient Gain Access to Investigational Drugs
Although the FDA has allowed limited access to investigational drugs to patients in certain circumstances who have very little hope of improvement with approved medications, the agency has recently issued new rules that help clarify who is allowed to have access to these investigational medications that are still in the testing phase.
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Dr. Riviera, graduate of Club Med School, is studying the effects of having only four fingers and a bright yellow complexion has on patient outcomes.
His image is used temporarily, in good fun, and without permission.
FDA Issues Draft Guidance on "IRB Contiinuing Review After Clinical Investigation Approval" This guidance is much more comprehensive for IRBs, investigators and sponsors than the current guidance document on the subject matter of continuing review from FDA.
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Medicare and Medical Technology — The Growing Demand for Relevant Outcomes
In deciding whether to pay for new medical technologies, the Centers for Medicare and Medicaid Services (CMS) is becoming more specific about its requirements for evidence of improved health outcomes.
Dr. Riviera, graduate of Club Med School, is studying the effects of having only four fingers and a bright yellow complexion has on patient outcomes.