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March 1, 2013News for the food and drug law community

  Drugs & Biologics 
  • Former FDA chief: Reform rules for clinical trials
    Changing the FDA's burdensome requirements for clinical trials could help double the number of new drug approvals, former FDA Commissioner Andrew von Eschenbach and University of Chicago public policy professor Tomas Philipson write. Phase III studies are unnecessarily large and cumbersome for more precise and personalized medicine. Adopting smaller, quicker adaptive studies with post-market oversight would mean greater innovation and a better economy. Bloomberg (2/28) Email this Story
  • Once-monthly Abilify gains FDA nod
    The FDA has granted Otsuka Holdings and H. Lundbeck approval for Abilify Maintena, a once-a-month injection for patients with schizophrenia. The drug was associated with significant delays in relapse compared with placebo, the company said. Bloomberg Businessweek (3/1) Email this Story
  • FDA grants Pernix subsidiaries approval for VITUZ, generic Ponstel
    Hawthorn Pharmaceuticals gained federal approval for its VITUZ oral solution to treat cough and upper respiratory allergies in adults. Cypress Pharmaceuticals also received final approval for its mefenamic acid capsules USP, a generic version of Ponstel Capsules, to address mild-to-moderate pain with primary dysmenorrhea. Hawthorn and Cypress were subsidiaries of Pernix Therapeutics Holdings. RTT News (2/28) Email this Story
  • Baxter submits hemophilia drug for FDA approval
    Baxter International filed a biologics license application with the FDA for approval to use FEIBA NF Nanofiltered and Vapor Heated, its anti-inhibitor coagulant complex treatment, in patients with hemophilia A or B and inhibitors. The application was based on a late-stage trial that found routine prophylactic treatment was associated with a 72.5% decrease in bleeding rates. Pharmaceutical Business Review Online (2/28) Email this Story
  • Draft on electronic submissions raises concerns for PhRMA, BIO
    Draft guidelines from the FDA on the electronic submission of data from clinical sites should address duplicative submissions that can delay site inspections, the Pharmaceutical Research and Manufacturers of America said. The Biotechnology Industry Organization said industry needs to know it can rely on technical specifications to allow long-term planning. (2/28) Email this Story
Eliminate TMF Inadequacies in Your Clinical Trials
To comply with regulatory requirements pertinent to clinical trials, every organization engaged in a clinical trial must manage and maintain all trial-related content, documents, and data in a manner that not only supports the claims to the safety and efficacy of a product, but that also serves as evidence the trial was conducted in a compliant manner. Download the whitepaper.
  Food & Dietary Supplements 
  • FDA unveils safety improvement plan for imported food
    The FDA released its International Food Safety Capacity-Building Plan, which aims to enhance food safety in countries that supply food to the U.S. The plan aims to provide technical assistance and capacity-building, support the exchange of information between governments and monitor international efforts' effects on food safety. (3/1) Email this Story
  Medical Devices 
  • FDA clears hip fixation implant from ArthroCare
    The FDA has cleared ArthroCare to market its SpeedLock HIP Knotless Fixation system for use in soft tissue bone fixation in the hip. The implantable device, which uses polyether-etherketone material, is intended primarily for patients in need of hip capsular repair and acetabular labral reattachment. RTT News (2/28) 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
Project Manager, Drug Safety and InnovationThe Pew Charitable TrustsWashington, DC
Associate Director, Regulatory Affairs CelgeneGreater New York City Area, NY
Counsel II, Legal (Anti-corruption)Gilead SciencesFoster City, CA
Click here to view more job listings.

The mark of mediocrity is to look for precedent."
--Norman Mailer,
American writer

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