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BSD Receives FDA Humanitarian Use Designation For The BSD-2000 Hyperthermia System
BSD Medical Corporation (NASDAQ:BSDM) announced that the U.S. Food and Drug Administration (FDA) has granted Humanitarian Use Device (HUD) designation for the company"s BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. This is the first of the two steps required to obtain Humanitarian Device Exemption (HDE) marketing approval, which requires BSD Medical to demonstrate the device"s safety and probable benefit in treating a disease or condition that affects fewer than 4,000 individuals in the United States per year. Now that FDA has granted the Humanitarian Use Designation for the BSD-2000, which confirms that the intended use population is fewer than 4,000 patients per year, BSD can file an HDE submission with the FDA. FDA has 75 days from the date of receipt of the HDE submission to grant or deny an HDE application. This period includes a 30-day filing period during which FDA determines whether the HDE application is sufficiently complete to permit substantive review. During this review, FDA may refine the indications for use which received HUD designation to finalize the indications for use for which HDE approval will be granted. This decision will be based on the data that are available to support the device"s HDE application. The company believes that the data previously submitted to FDA and reviewed by the agency in the company"s pending PMA application can be used to support the HDE approval, and that this previous review may expedite marketing approval for the BSD-2000.
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G8 Summit Begins Wednesday; WFP Calls For 'Twin-Track' Approach To Food Security
The G8 summit is scheduled to open Wednesday in L"Aquila, Italy. The World Food Program (WFP) on Tuesday issued a statement praising the G8 leaders" focus on food security and calling for support of its efforts to combat hunger among the world"s poorest people, Xinhua reports. In the statement, WFP Executive Director Josette Sheeran recommended leaders take a "twin-track" approach to food security, which includes supporting long-term agricultural production along with immediate hunger assistance.
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Tiller Murder Prompts Abortion Providers To Re-Evaluate Protective Measures, Security
The recent murder of Kansas abortion provider George Tiller has prompted other providers nationwide to reassess their need for protective measures against violent actions from opponents of abortion rights, the AP/San Francisco Chronicle reports. In the days following Tiller"s murder, many clinic officials nationwide said that they had contacted law enforcement and examined their existing security measures. U.S. Attorney General Eric Holder also ordered the U.S. Marshals Service to provide security to several clinicians and facilities. According to the AP/Chronicle, violence against abortion providers in the 1980s and 1990s forced many to take various precautionary measures in and around their clinics, while some underwent training to protect themselves.Kate Michelman, former president of NARAL Pro-Choice America, said the election of former President George W. Bush, an abortion-rights opponent, helped alleviate some violence against abortion providers. However, she said that she believes Tiller"s murder might indicate the situation is changing during the first months of President Obama"s administration. Obama has rejected abortion-rights opponents" calls for restrictions on the procedure and also reversed the "global gag rule," or "Mexico City" policy.Michelman said, "Historically, when those who oppose a woman"s right to decide are frustrated politically, they get more violent," adding, "I have been thinking about this ever since the [Obama] election." She said that some providers will remain fearful even though she believes clinics are now safe. "In the end ... if someone is out to get you and they are determined and have a chorus encouraging them, ... there"s not much you can do to stop them," Michelman said. Provider LeRoy Carhart, who provided abortion services at Tiller"s clinic, said that people who commit violence against abortion providers should be charged with hate crimes (Hanna, AP/San Francisco Chronicle, 6/3).

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