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FDA Issues Advertising Guidelines On Product Risk Information
FDA on Tuesday posted on its Web site advertising guidelines for drugmakers and medical device manufacturers, offering suggestions on how to present risk information to health care professionals and consumers, the Wall Street Journal reports. Agency officials said the industry had asked for guidance on how to comply with its rules, which require a balanced presentation of a product"s risk and effectiveness. Exclusion or minimization of risk information is the most commonly cited violation each year in FDA-issued warnings or enforcement letters. The new guidelines include detailed information on how aspects such as font, types of contrast and white space in print materials can appropriately present risk information. According to the Journal, the 24-page document is not binding. FDA will accept public comments for 90 days prior to issuing final guidelines (Corbett Dooren, Wall Street Journal, 5/27).
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Yissum Signs A Collaboration Agreement With Aurum Ventures MKI For The Development Of Breakthrough Liver-Bypassing Oral Drug Delivery Nanotechnology
Yissum Research Development Company Ltd., the Technology Transfer Company of the Hebrew University of Jerusalem, announced today at the ILSI-Biomed Israel 2009 conference, it has signed an agreement with Aurum, Ventures MKI, the technology investment arm of Mr. Morris Kahn, for the development of a nanotechnology controlled release drug delivery platform that increases the bioavailability of orally administered lipophilic drugs. The technology was developed by Prof. Simon Benita at the Hebrew University"s School of Pharmacy.
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The 2009 AMSA National Leadership Development Seminar, Australia
The AMSA National Leadership Development Seminar will be held from the 7th to the 9th of September 2009.
Mental Health

National All Schedules Prescription Electronic Reporting (NASPER) Act Receives Senate Support

The American Society of Interventional Pain Physicians (ASIPP) announced that the National All Schedules Prescription Electronic Reporting (NASPER) Act has received the support of Senator John D. Rockefeller IV of West Virginia and Senator Bob Corker of Tennessee. NASPER was unanimously passed by both the House and the Senate and signed into law on August 11, 2005 by President George W. Bush, and received preliminary funding of $2 million for the Fiscal Year 2009 and 2010. Proposed by ASIPP, with the support of the American Medical Association, the American Society of Anesthesiologists and other organizations, NASPER"s purpose is to provide and improve patient access to quality care. It was also created to protect patients and physicians from the deleterious effects of controlled substance misuse, abuse and trafficking. The ultimate goal of NASPER is to have a coordinated prescription monitoring program in all 50 states, which could save hundreds of millions of dollars in prescriptions in the Medicaid and Medicare programs. "While the preliminary funding of NASPER is a promising start, it is imperative to secure full funding in order to realize its full potential and possibly save countless numbers of lives," said Dr. Laxmaiah Manchikanti, ASIPP CEO and Chairman of the Board. "The abuse of prescription drugs continues to be a problem that plagues millions of Americans and their families every day," said Rep. Ed Whitfield who first authored the legislation in the 108th Congress. "NASPER is a powerful weapon in the fight against prescription drug abuse that will allow physicians to detect abuse and prevent the practice of doctor shopping across state lines. I am pleased that NASPER has, at long last, received the funding that it needs to be implemented and start saving lives." According to the National Institute of Drug Abuse, abuse of prescription medications is on the rise. Prescription drug monitoring programs are an important tool to help and track illegal activity related to the prescription of these drugs. Senators Rockefeller and Corker have stated that NASPER is a "vital tool for states to combat substance abuse," and urge the Appropriations Committee to provide $25 million for the 2010 Fiscal Year. Currently, there are 38 states that individually fund their own prescription monitoring programs based on requirements originally set by NASPER. With additional appropriated support, states will have the res necessary to enhance their programs and meet statutorily defined requirements. "NASPER has made strides since its inception in 2005, but the endorsement of Senator Rockefeller and Senator Corker will hopefully move NASPER into the next crucial phase," said Dr. Manchikanti. "We are so grateful for the support from the senators and those who have shown dedication over the years, especially the tireless efforts of Rep. Ed Whitfield, Rep. Bart Stupak, Sen. Jeff Sessions, and Sen. Richard Durbin." About The American Society of Interventional Pain Physicians ASIPP"s mission statement is to promote the development and practice of safe, high quality, cost-effective interventional pain management techniques for the diagnosis and treatment of pain and related disorders, and to ensure patient access to these interventions. Founded in 1998 by current CEO Laxmaiah Manchikanti, MD, ASIPP is a rapidly growing not-for-profit organization that supports the needs of physicians who practice Interventional Pain Management across the country. Since its inception, the organization has had substantial impact on the practice of interventional pain medicine, resulting in an impressive list of major achievements. In 2005, ASIPP succeeded in passing The National All Schedules Prescription Electronic Reporting Act (NASPER), which provides and improves patient access to quality care, and protects patients and physicians from the deleterious effects of controlled substance misuse, abuse and trafficking. ASIPP is headquartered in Paducah, KY and currently has over 5,000 members. The American Society of Interventional Pain Physicians


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