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January 31, 2013News for the food and drug law community

  Drugs & Biologics 
  • Panel doubts agents' role in improving Alzheimer's diagnosis
    The Medicare Evidence Development & Coverage Advisory Committee showed a lack of confidence in the use of imaging agents to detect brain plaques linked to Alzheimer's disease risk. Only one of the 12 voting members expressed intermediate to high confidence that the agents will help improve outcomes in patients showing early signs of memory problems. This lack of confidence may lead to CMS reimbursement problems for Eli Lilly & Co.'s FDA-approved imaging agent Amyvid. Lilly said it is confident of the usefulness of its product in evaluating patients suspected of having Alzheimer's. Reuters (1/30) Email this Story
  • Earlier challenges will curb patent settlements
    Allowing an opposition proceeding sooner could eliminate low-quality drug patents early in an inexpensive and relatively fast proceeding, writes Alfred Engelberg, former patent counsel of the Generic Pharmaceutical Association. The growth of the generic drug industry has rendered many of the provisions of 1984's Hatch-Waxman Act unnecessary, and change is needed to end a system of patent settlements and low-quality patents that stifle competition, Engelberg writes. Politico (Washington, D.C.) (1/30) Email this Story
  Global Focus 
  Food & Dietary Supplements 
  Medical Devices 
  • Eucomed comments on EU medtech scrutiny in position paper
    Eucomed calls the scrutiny procedures in the European Commission's proposed regulation of medical devices "inappropriate," saying the regulation will not help ensure device safety and will instead create a false sense of security while duplicating regulatory efforts and creating financial burdens for new companies. The proposal would create a Medical Device Co-ordination Group to review products and clinical trial evidence. Eucomed advocates an alternative "systematic authority control procedure on notified bodies and clinical review that go beyond the current proposed measures," including measures to keep stakeholders involved in the process. Clinica (subscription required) (1/31) Email this Story
  FDLI Items 
  • Cosmetics Regulatory Process Primer -- Instant access, purchase and download now
    The Cosmetics Regulatory Process primer provides a baseline of key legal concepts and issues from experts in the field; describing, in detail, the basis of the underlying standards governing cosmetics and how cosmetic oversight differs from the regulation of food, drugs or medical devices. With this basic guide, readers will develop a firm grasp of the legal and regulatory concepts for cosmetics. Other available primers include:
    • The Medical Device Review Process: A Focus on Pre-Market Requirements
    • Controlled Substances: FDA and DEA Regulation of Pharmaceuticals
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  • Pharmacy Compounding -- Join the discussion on Feb. 12 – Panel highlight
    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
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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
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
Compliance Counsel - PrivacyOtsukaPrinceton, NJ
Corporate AttorneyOtsukaRockville, MD
Corporate AttorneyOtsukaPrinceton, NJ
Food and Drug AssociateHunton & Williams LLPWashington, DC
Regulatory ConsultantThe Weinberg GroupWashington, DC
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--John Gunther,
American author and journalist

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