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    From 100 Hours to 1: FDA Dramatically Simplifies its Compassionate Use Process

    In response to repeated criticism that terminally ill patients find it too difficult to obtain access to experimental and potentially life-saving drugs, the US Food and Drug Administration (FDA) has announced changes to its "compassionate use" process in the hopes of making it easier for physicians to request access to medical products on behalf of their patients. Background FDA's "compassionate use" process—formally known as its Expanded Access Program—is meant to allo...
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    EMA Touts Big Year for Veterinary Products

    The European Medicines Agency (EMA) recommended 20 new veterinary medicines for approval in 2014, the highest number in the past five years, according to data provided by the regulator. The agency also boasts that it received 29 requests for classification of medicines intended for rare diseases or species with a small population, the most the agency has seen in a single year. Addressing Rare Diseases in Animals In 2009, EMA’s Committee for Medicinal Products for Vete...
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    FDA Sees 92% Increase in Requests for Compassionate Access to Medicines in 2014

    Last year, the US Food and Drug Administration (FDA) received—and approved—substantially more requests for "compassionate" access to potentially life-saving treatments than any time since at least 2010, according to new data provided by the regulator. Background The data relate to FDA's "expanded access" program—sometimes called its "compassionate use" program—which was created to allow a pathway for terminally or critically ill patients to obtain access to drugs they...
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    New Bill Would Reduce FDA Burden on Research-Use Devices

    A new bill introduced in the House of Representatives by a prominent Republican legislator would make it easier for companies to distribute investigational medical devices explicitly labeled as being "for research use only (RUO)." The Medical Testing Availability Act of 2015 , sponsored by Rep. Michael Burgess (R-TX), the vice chairman of the Energy and Commerce Committee's Subcommittee on Health, is similar to an identically titled bill introduced by Burgess in 2013 ....
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    Pharmaceutical Companies Look to Create Better Compassionate Use Process

    • 11 December 2014
    The prominent US pharmaceutical trade group PhRMA has released an updated set of principles it says reflects the US pharmaceutical industry's "commitment" to provide patients with life-threatening diseases access to investigational therapies on a compassionate-use basis. Background The policy is meant to accommodate patients who are otherwise not eligible to participate in a clinical trial for a new drug, either because they are too sick to participate, have a disqualif...
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    Legislation Seeks to Overhaul FDA's Compassionate Use Program

    New legislation introduced in the House of Representatives would makes changes to the US Food and Drug Administration's (FDA) "expanded access"—sometimes called " compassionate use "—policies in the hopes of making it easier for terminally ill patients to access potentially life-saving drugs. Background Under normal circumstances, companies seeking FDA approval for a new drug will first ask regulators for permission to begin a clinical trial using an application known a...
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    FDA Recommends New Testing Standards for Home Use Devices

    A final guidance document issued by the US Food and Drug Administration (FDA) aims to make medical devices used by patients in their homes safer and more reliable. Background In general, medical devices can be divided into two categories: Those intended to be used in professional settings by healthcare professionals, and those intended to be used in home healthcare settings by patients or caregivers. The latter category, often referred to as "home use devices," is ass...
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    Laws Spreading That Allow Terminal Patients Access to Experimental Drugs

    Earlier this month, Arizona voters  approved a referendum  that allows terminally ill patients to receive experimental drugs and devices. It’s the fifth state to approve a “right-to-try” law this year. Supporters say the laws give dying patients faster access to potentially life-saving therapies than the Food and Drug Administration’s existing  “expanded-access” program , often referred to as “compassionate use.” But critics charge they’re feel-good laws that don’t addre...
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    Company's Compassion Leads to Clinical Hold on Experimental Drug

    If you're trying to understand why some drug companies are reluctant to allow desperate patients to enroll in their early-stage clinical trials, look no further than the case of CytRx Corporation, whose clinical trial for the drug compound aldoxorubic is now partially on hold following the death of a patient enrolled in the trial on a compassionate use basis. Background Companies seeking approval to market a drug product in the US must first prove to the US Food and Dru...
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    FDA Authorizes Sixth Device to Help in Fight Against Ebola

    The US Food and Drug Administration (FDA) has once again given its blessing to a new diagnostic tool meant to help identify treatments for Ebola—the sixth time it has used its emergency authority to do so in the last four months. Background In March 2013, FDA was given a host of new authorities and responsibilities under the  Pandemic and All-Hazards Preparedness Reauthorization Act ( PAHPRA ) , a piece of legislation intended to bolster the government's ability to ...
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    FDA Authorizes Use of New, Substantially Faster Ebola Diagnostic Tests

    The US Food and Drug Administration (FDA) has granted emergency use authorizations (EUAs) to two new diagnostic tests meant to help health professionals to accurately diagnose the Ebola Zaire virus in record time. Background In March 2013, FDA was given a host of new authorities and responsibilities under the  Pandemic and All-Hazards Preparedness Reauthorization Act  ( PAHPRA ), a piece of legislation intended to bolster the government's ability to respond to health ...
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    Think Tank Seeks Ebola Info from FDA, Calling it a Test Case for Compassionate Use System

    A libertarian-leaning think tank is pressuring the US Food and Drug Administration (FDA) to release information regarding the internal approval processes it used to permit two US citizens stricken with Ebola access to Mapp Biopharmaceuticals' ZMapp, an experimental drug. Background In August 2014, the American public became fixated on an outbreak of Ebola in West Africa after two US missionaries, Dr. Kent Brantley and Nancy Writebol, became infected with the disease. In...