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Prestigious Program Encourages Young Investigators In Academic Gastroenterology
The Foundation for Digestive Health and Nutrition has announced the 2009 American Gastroenterological Association (AGA) Foundation Research Scholars. The grants have been awarded to five outstanding young gastroenterologists who promise to make significant strides in the field of gastrointestinal research.
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Moderately Reduced Carbohydrate Diet Keeps People Feeling Full Longer
A modest reduction in the amount of carbohydrates eaten, without calorie restriction and weight loss, appears to increase a sense of fullness, which may help people eat less, a preliminary study found. The results were presented at The Endocrine Society"s 91st Annual Meeting in Washington, D.C.
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Catholic Law Professors Debate Obama Administration's Efforts To Reduce Need For Abortion
Catholic constitutional law professors Doug Kmiec of the Pepperdine University School of Law and Robert George of Princeton University on Thursday during a forum at the National Press Club debated the Obama administration"s abortion policies and whether opposing sides in the abortion-rights debate should work toward finding "common ground," the Washington Times reports. Kmiec -- a Republican who broke rank with many Catholics and supported President Obama"s run for the presidency -- stressed that the president is serious about reducing the need for abortion. However, George "challenged the administration to do something concrete," such as ban certain abortion procedures, according to the Times. He said that Obama "rejects what we and pro-lifers propose is common ground. ... He does not believe human beings acquire rights until after birth."Kmiec and George also debated the role of Catholics in politics, such as whether Catholics who support abortion rights should be denied Holy Communion or whether Catholic bishops should speak out against politicians who support abortion rights. In April 2008, a Los Angeles priest denied Kmiec Communion because of his support for Obama. Kmiec asked, "Are we as Catholics expected to sit on the sidelines aloof with the truth talking to ourselves or are we to engage our fellow citizens and offer that faith? The 2008 election was very much a test of that." He said that he does not believe that intimidation is the correct way to address abortion-rights issues, adding that the "denial of Communion is intimidation." Kmiec said that Catholic bishops" opposition to abortion-rights supporters who are Catholic "is not either an effective nor a Catholic approach. Nor is it a Catholic approach to endorse candidates. Yet certain bishops endorse candidates. Nor should churches allow materials in their vestibule saying it is a sin of the highest order to cast a vote for Barack Obama." He noted that 54% of Catholics voted for Obama.George opted to focus on Obama"s legislative record instead of the issue of Catholics in politics. He said, "Obama"s record as an activist, legislator and now as president is that an unborn baby possesses no rights. Throughout his career, he has denied every fundamental legislation that would discourage its practice or limit its liability" (Duin, Washington Times, 5/29).
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BioMimetic Therapeutics Submits First Two PMA Modules To FDA

BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced it has submitted both the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its Premarket Approval (PMA) application for marketing of Augment Bone Graft in the U.S. These are two of the three parts, or modules, required for a complete PMA application to the FDA. The Company intends to file the third and final module, containing the clinical data, in the fourth quarter of 2009. A modular submission breaks the PMA document into three sections or "modules" filed at different times that together become a complete application. The modular approach allows the applicant to potentially resolve any concerns noted by FDA earlier than would occur with a traditional PMA application, and may ultimately shorten the review and approval timeline. "The submission of the first two PMA modules is a significant accomplishment for BioMimetic," commented Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. "These submissions allow FDA to begin their review of these modules well in advance of receiving the final clinical data later this year. We believe this modular strategy will facilitate the most efficient and timely review and ultimate FDA approval of Augment Bone Graft for orthopedic applications." The Company also announced today it has achieved a new ISO 9001:2008 certification and ISO 13485:2003 recertification. These certifications are maintained by the International Organization of Standardization, which is the world"s largest developer and publisher of international industrial and commercial standards for business. Companies that achieve these certifications are recognized within the medical device industry and by international regulatory bodies as operating at the highest standards of quality. This certification provides external objective evidence and recognition of leading management systems, achievement of continual high quality standards and customer satisfaction. "BioMimetic achieved certification to the new 2008 version of ISO 9001, as opposed to the prior 2000 version, six months ahead of schedule," indicated John McKay, vice president of quality and environmental, health and safety for BioMimetic Therapeutics. "The Company is one of the first in the United States to achieve the new ISO 9001:2008 certification." Additionally, the Company received ISO 13485:2003 recertification, which represents the requirements that medical device manufacturers must incorporate into their management systems. The certification emphasizes meeting regulatory as well as customer requirements, risk management and maintaining effective processes specific to the safe design, manufacture and distribution of medical devices. BioMimetic Therapeutics


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