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March 18, 2009News for the biotech, medical device, drug and food regulatory profession

  Drugs & Biologics 
  • FDA deputy chief cautions staff on leaking information
    FDA Deputy Commissioner Frank Torti issued a staff memorandum restricting the release of intra- and interagency documents as well as commercial information to prevent confidentiality complaints against the agency or its employees. "This 'all-hands memo' was simply a prudent reminder to staff that while we are committed to the president's principles of transparency, as a regulatory agency we also need to be mindful of several categories of confidential information we need to respect every single day," an FDA spokeswoman said. The Wall Street Journal (tiered subscription model)/Health Blog (3/17) Email this Story
  • FDA warns of increased bleeding risk tied to rivaroxaban
    An FDA review showed that anti-coagulant rivaroxaban outperformed enoxaparin in stopping blood clots but almost doubled the risk of bleeding. Johnson & Johnson, which developed rivaroxaban with Bayer, said the treatment has a "favorable safety profile" and that all anti-clotting medicines come with bleeding risk. On Thursday, a panel of FDA advisers will evaluate the drug for approval. Jones Newswires (3/17) Email this Story
  • No class-action trial for Vioxx refunds, N.J. judge says
    A judge at the New Jersey Superior Court rejected class-action certification for a lawsuit against Merck & Co. over the reimbursement of consumers' out-of-pocket expenses for painkiller Vioxx. Although the ruling might "sound a death knell for the claims of individuals," a class-action trial would be "unmanageable," Judge Carol Higbee wrote in her 18-page decision. Reuters (3/17) Email this Story
  • U.N. arm issues guidelines to curb illegal online drug trade
    The United Nations' International Narcotics Control Board released guidelines on how to stop illegal sales of prescription drugs on the Internet. The guidance was issued because a growing number of illegitimate online pharmacies are selling controlled substances without a prescription. Reuters (3/17) Email this Story
  Health Care in Transition 
  • Federal health benefits might be model for national plan
    The White House is studying the federal government's health insurance program as it tries to figure out how to overhaul health coverage nationwide, says Neera Tanden, HHS counselor for health reform. While it's unlikely the government will apply the same program on a national scale, Tanden says, it can be considered a model for quality of care and choices provided. Some critics say the program is too costly and that the government would be better off using more efficient programs -- such as Medicare -- as a model. Government Executive (3/16) Email this Story
  • Officials: Providers need more details on IT funding
    Health care providers could face financial problems unless they fully understand the details of the health IT funding available under the economic-stimulus package, speakers said at a Washington briefing. Part of the $2 billion in funding allotted for the Office of the National Coordinator should be used to inform providers about the measure's key points, such as the incentives and financial risks linked to health IT adoption, said Neal Neuberger, executive director of the Institute for e-Health Policy. Government Health IT magazine (3/2009) Email this Story
  • ONCHIT unveils data on health IT network via Web
    The Office of the National Coordinator of Health Information Technology has unveiled online materials that organizations can use to join the Nationwide Health Information Network. Technical requirements, testing materials and trust agreements created during trial deployments of the network are among the available information. Healthcare IT News (3/17) Email this Story
  Food & Dietary Ingredients 
  Featured Content 

  Medical Devices 
  • Study shows doubling of radiologic tests on pregnant women
    A retrospective study showed that the number of radiologic exams, including nuclear medicine, CT, fluoroscopy and plain-film X-ray imaging, administered on pregnant women at two hospitals in Rhode Island more than doubled from 1997 to 2006. Although imaging during pregnancy generally is safe and helpful in detecting possible life-threatening conditions, the "study should raise awareness about imaging trends in pregnant patients and help us continue in our efforts to minimize radiation exposure," a researcher said. (3/17), U.S. News & World Report/HealthDay News (3/17) Email this Story
  FDLI Items 
  • Offered one time per year: Introduction to Biotechnology Law and Regulation, May 28 and 29. Register at early-bird rates today
    Register for this meeting to obtain an overview of the regulatory process with regard to human biotechnology products, including biologicals, drugs and tissue. The program will help you comply with FDA's regulations and identify and address potential areas for regulatory problems. You will also acquire a clearer understanding of how other administrative agencies are involved with the regulation of human biotechnology products and the framework of requirements they enforce, including the clinical trial database and postmarket safety requirements. There also will be an update on generic, or follow-on, biologics. Learn more about this program. Register online. Register by fax. Email this Story
  • New book from FDLI: "Global Pharmacovigilance Laws & Regulations: The Essential Reference." Purchase at a pre-publication price
    As health care professionals increasingly rely on biomedical software to help treat patients, it is also becoming increasingly complex. This user-friendly guide summarizes key regulations promulgated by FDA and CMS and provides key reference materials and documents for use by regulatory and compliance specialists, medical device attorneys and health care professionals. This landmark book covers FDA regulation of software as a medical device; software validation; medical imaging software regulation; electronic recordkeeping; software used in clinical trials; laboratory information management systems; and HIPAA privacy rules and security standards. Preview now. Purchase your copy at a pre-publication price. Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

Legal Counsel IIPhysio-ControlRedmond, WA
Senior Corporate Attorney, Commercial/HealthcareAstellas Pharma USDeerfield, Illinois
Associate Director Regulatory Affairs (OTC)Johnson & JohnsonFort Washington, PA
Health Policy Analyst and ProgrammerGententechWashington DC

Be a friend to thyself, and others will be so, too."
--Thomas Fuller,
English clergyman and historian

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