Reading this on a mobile device? Try our optimized mobile version here: http://r.smartbrief.com/resp/ekdvCfbwocfblhgJxtdx

February 12, 2013News for the food and drug law community

  Drugs & Biologics 
  • Footnote in court hints at new FDA rules for generic warnings
    The FDA may revise regulations so that makers of generic drugs can update labels to warn patients about risks, Ed Silverman writes. The Justice Department filed a friend-of-court brief in a case concerning generic drugs, and it carried this footnote: "This office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances." Pharmalot.com/Pharma Blog (2/11) Email this Story
  • Early trials may be enough for innovative drugs to win FDA approval
    The FDA granted "breakthrough" status to three promising experimental drugs as part of efforts to speed market entry for treatments of life-threatening conditions. "We expect many of these would come available very quickly with Phase 1 data," FDA Center for Drug Evaluation and Research Director Janet Woodcock said. Applications for breakthrough status have been made for 18 other treatments, she said. Bloomberg Businessweek (2/12) Email this Story
  Food & Dietary Supplements 
  • Supreme Court to hear case on genetically modified soybeans
    A Supreme Court case could determine whether Monsanto and other seed producers can prevent farmers from re-planting genetically altered crops. An Indiana farmer bought progeny soybeans from a grain elevator for planting. A ruling against Monsanto "would devastate innovation in biotechnology," according to the company's brief. The Washington Post (2/9) Email this Story
  Medical Devices 
  • Optovue scores 510(k) clearance for OCT system database
    Optovue has been cleared by the FDA to incorporate a normative database into the firm's iVue spectral-domain optical coherence tomography device. The iVue SD-OCT technology can use the database to enable the quantitative comparisons of the optic disc and other areas of the eye, as well as tailor OCT scans according to a patient's age, optic disc size and other factors. Healio (2/8) Email this Story
  FDLI Items 
  • 2013 conference calendar -- speak, register & save the dates!
    There are plenty of speaking opportunities available for this year's FDLI conferences. Please e-mail our development team if you are interested in participating or have any session/program ideas. FDLI members routinely receive at least a 20% discount on FDLI conferences, webinars and publications. Upcoming programs include:
    • Medical Device Compliance, Regulation and Litigation Conference | March 4 | Washington, D.C.
    • Introduction to Drug Law and Regulation | April 3-4 | Washington, D.C.
    • Introduction to Medical Device Law and Regulation | April 3-4 | Washington, D.C.
    • FDLI Annual Conference | April 23-24 | Washington, D.C.
    • FDLI International Conference | June 6-7 | Beijing, China. New date!
    • Advertising & Promotion Conference | Sept. 16-17 | Washington, D.C.
    • Food Advertising: Claims, Litigations and Strategies | Oct. 8 | Location TBD
    • FDA Regulation of Tobacco Products | Oct. 17 | Washington, D.C.
    • Enforcement, Litigation and Compliance | Dec. 10-11 | Washington, D.C.
    Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

 
Position TitleCompany NameLocation
Advertising and Promotions CounselPrinceton Legal Search Group, LLCWashington, D.C., DC
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
Click here to view more job listings.

  SmartQuote 
Do not teach your children never to be angry; teach them how to be angry."
--Lyman Abbott,
American theologian, author and editor


Email this Story

 
 
Subscriber Tools
     
Print friendly format | Web version | Search past news | Archive | Privacy policy

Advertise
Account Director:  Meryl Harold (202) 407-7828
Job Board:  Jackie Basso (202) 407-7871
 
Read more at SmartBrief.com
A powerful website for SmartBrief readers including:
 
 
 Recent FDLI SmartBrief Issues:   Lead Editor:  Tom Parks
     
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004
 
 
© 1999-2013 SmartBrief, Inc.® Legal Information