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January 23, 2013News for the food and drug law community

  Drugs & Biologics 
  • Ampio's DME drug receives FDA nod
    The FDA has granted Ampio Pharmaceuticals approval for its oral drug Optina to address diabetic macular edema. The drug obtained 505-b-2 status last year, making it eligible for approval based on a single study. RTT News (1/22) Email this Story
  • FDA allows deadline to seek rehearing to expire in off-label case
    The FDA didn't pursue a rehearing of the 2nd U.S. Circuit Court of Appeals' decision to overturn a former sales rep's conviction over the promotion of off-label uses of a drug before the Jan. 16 deadline. The decision suggests the FDA might not challenge the ruling though it still could seek a Supreme Court hearing, Ed Silverman writes. An FDA spokeswoman said the agency "does not believe that the decision will significantly affect the agency's enforcement of the drug misbranding provisions of the Food, Drug & Cosmetic Act." Blog (1/22) Email this Story
7 keys: Put real-world evidence into action
Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
  Global Focus 
  • PhRMA, MSF weigh in on drug patent case in India
    The Indian Supreme Court is weighing the importance of protecting pharmaceutical innovation and providing affordable access to drugs after the country's generic-friendly patent law was challenged by a drugmaker's appeal concerning a cancer treatment. "The whole case is about encouraging generics and the central role they have had in treating deadly diseases," said Patricia Kahn of Medecins Sans Frontieres. Patents foster improved treatments, PhRMA's Mark Grayson said. "The kinds of tactics that MSF is taking will only end up hurting the people they are trying to help, because it could end up hurting innovation in areas where they would like to see more," Grayson said. Scienceline (1/22) Email this Story
  Food & Dietary Supplements 
  • OMB reviews USDA's products labeling proposal
    The White House Office of Management and Budget is reviewing a proposal on labeling mechanically tenderized beef products submitted by the USDA's Food Safety and Inspection Service. The proposal calls for the inclusion of cooking instructions on the labels of the products to notify consumers that 160 degrees is the minimum internal temperature needed to prepare the meat for consumption. (1/23) Email this Story
  • USDA confirms meat products recall due to undeclared use of MSG
    The USDA's Food Safety and Inspection Service announced the recall of about 79,400 pounds of marinated chicken and pork products by C & H Meat due to the use of monosodium glutamate that is not listed on the label. Affected products include bulk packages of Korean Brand BBQ Flavored Spicy Boneless Chicken Leg Meat and Korean Brand BBQ Flavored Spicy Pork Butt. Food Business Review (1/23) Email this Story
  Medical Devices 
  FDLI Items 
  • 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
    Email this Story

  • Volunteer to serve on an FDLI committee -- Deadline is Friday
    FDLI committees are comprised of volunteers who advise FDLI staff and provide expertise for program and publication development. The Institute depends on the dedication of our committee volunteers to help drive our mission and create a stronger food and drug law community. Current committees include: Academic Programs, Audit, Austern Writing Awards, Drugs and Biologics, Editorial Advisory Board (Journal), Editorial Advisory Board (Primers/Monographs), Editorial Advisory Board (Policy Forum), Editorial Advisory Board (Update), Finance, Food and Dietary Supplements, Medical Devices and Tobacco. More details online. Typical committee service is a three-year term beginning at Annual Conference each year (usually in April). If you would like to be considered for committee service (April 2013-April 2016), please e-mail Michael Sprott at by Friday. Committee appointments will be announced in March. Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

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Sales Engineer 108473-02 UTC Climate, Controls & Security Carrier CorporationAustin, TX
Food and Drug AssociateHunton & Williams LLPWashington, DC
Compliance Counsel - PrivacyOtsukaPrinceton, NJ
Corporate AttorneyOtsukaRockville, MD
Corporate AttorneyOtsukaPrinceton, NJ
Regulatory ConsultantThe Weinberg GroupWashington, DC
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Shyness has a strange element of narcissism, a belief that how we look, how we perform, is truly important to other people."
--Andre Dubus,
American writer

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