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February 8, 2013News for the food and drug law community

  Drugs & Biologics 
  • Guidance for new Alzheimer's treatments unveiled by FDA
    The FDA released a nine-page draft guidance document that recommends ways to develop medicines aimed at treating Alzheimer's disease before the onset of brain damage and memory loss. "This draft guidance is intended to serve as a focus for continued discussions between the FDA and pharmaceutical sponsors, the academic community, advocacy groups, and the public," the FDA Center for Drug Evaluation and Research's Dr. Russell Katz said. The Pharmaceutical Research and Manufacturers of America has identified a lack of noninvasive, validated biomarkers and the nature of the illness itself as reasons behind statistics that show only three drugs have been approved since 1998, while 101 candidates have failed. Modern Healthcare (subscription required) (2/7), The Hill/RegWatch blog (2/7), Reuters (2/7) Email this Story
  • Opioid labeling petition is debated at FDA hearing
    Pain patients and people who lost family members to addiction were among the groups represented at an FDA hearing on a petition on the labeling of opioid drugs. A petition from Physicians for Responsible Opioid Prescribing calls for restrictions on the marketing and use of opioid painkillers, including for moderate noncancer pain. Other groups said the proposal could block access to opioid drugs for patients with legitimate pain and that there are challenges in attempting to distinguish cancer pain and noncancer pain due to the long-term complications of the disease. MedPage Today (free registration) (2/7), The Wall Street Journal (2/7) Email this Story
  • FDA finds more bogus Avastin in U.S. supply chain
    Counterfeit versions of bevacizumab, which is sold in the U.S. as Genentech's Avastin, have entered the U.S. drug supply chain, according to a warning from the FDA. The bogus drug is labeled as Roche Holding's Altuzan. That drug is not approved for sale in the U.S. Testing found one or more batches of the suspect drug lacked the active ingredient, and the fake products are linked to Medical Device King, Pharmalogical and Taranis Medical. HealthDay News (2/6), Yahoo/The Associated Press (2/6) Email this Story
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  Global Focus 
  • Opinion: Upload complete drug study data on EU's public database
    Drugmakers and researchers should publish comprehensive findings from clinical studies on the public European Union database, writes the Labour Party's Glenis Willmott, a member of the European Parliament. Summaries may be influenced by bias and could inflate drugs' value, Willmott writes. Financial penalties should be used to enforce transparency, Willmott writes. Public Service Europe (2/6) Email this Story

  Food & Dietary Supplements 
  Medical Devices 
  • Senate bill takes aim at 2.3% medical device tax
    A bipartisan bill that would repeal the 2.3% medical device tax has been introduced in the Senate. Industry leaders and lawmakers in favor of the repeal said the tax will threaten job growth and medical innovation. "In order to compete in the global economy our medical device businesses need a level playing field," said Sen. Amy Klobuchar, D-Minn. Reuters (2/7) Email this Story
  FDLI Items 
  • Compounding: Join the discussion on Feb. 12 -- phone option available
      
    With newly proposed legislation, the courts split, and statutory authority at issue, this is the ideal time for stakeholders to convene, communicate, and explore "what's next" in compounding oversight. Join FDLI for our upcoming program -- Pharmacy Compounding: An FDLI Dialogue-- on Feb. 12 in Washington, D.C. During the first panel, Regulation of Pharmacy Compounding: Historical Analysis, panelists will lead an interactive discussion on the historical framework of the regulation of pharmacy compounding. Panelists include:
    • Douglas B. Farquhar, director, Hymann, Phelps & McNamara P.C.
    • Casey Kozlowski, R.Ph., M.B.A., director, retail ancillary services, Walgreen Co.
    • William A. McConagha, partner, Sidley Austin LLP
    Email this Story

  • Medical Device Compliance, Regulation and Litigation Conference -- March 4 -- CDRH confirmed
     
    At this conference, now in its second year, attendees will hear Carolyn "Cassie" Scherer, policy adviser, office of the center director, CDRH, FDA, and Mary Weick-Brady, senior policy adviser, office of the center director, CDRH, FDA, discuss in detail the most significant recent and upcoming medical device compliance, regulatory and enforcement actions. Additionally, legal experts will analyze the most important cases of 2012 and detail what to expect in 2013 in litigation and regulatory developments, including key products liability issues. Register now and save $100. Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

 
Position TitleCompany NameLocation
Sales Engineer 108473-02 UTC Climate, Controls & Security Carrier CorporationAustin, TX
FDA AssociateK&L GatesMultiple Locations, United States
Food and Drug AssociateHunton & Williams LLPWashington, DC
FDA/ORA/Asst Commissioner for Operations, Food and Drug Administration, Office of Regulatory AffairsFood and Drug AdministrationRockville, MD
FDA/ORA/Regional Food and Drug DirectorFood and Drug Administration/Office of Regulatory AffairsMultiple Locations, United States
Click here to view more job listings.

  SmartQuote 
After you've done a thing the same way for two years, look it over carefully. After five years, look at it with suspicion. And after ten years, throw it away and start all over."
--Alfred E. Perlman,
American businessman


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