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

February 22, 2013News for the food and drug law community

  Drugs & Biologics 
  • Compounders back FDA regulation of certain operations
    The International Academy of Compounding Pharmacists will support a law subjecting compounding pharmacies that work like manufacturers to FDA oversight and regulations, the group's executive vice president said. The group previously asserted that compounding pharmacies should be overseen by state pharmacy boards. The Washington Post (2/21) Email this Story
  • EU denies Vivus' obesity drug for the second time
    The European Committee for Medicinal Products for Human Use denied for the second time Vivus' diet pill Qsymia, which was to be marketed as Qsiva in Europe. Vivus said the obesity drug wouldn't be approved unless its heart safety is proven by a major study. Yahoo/Reuters (2/21) Email this Story
  • Larger vial is OK'd for CSL Behring's Privigen
    The FDA approved use of 40-gram vials for the sale of CSL Behring's Privigen, a treatment for chronic immune thrombocytopenic purport and primary immunodeficiency. The immune globulin product will continue to be sold in 5, 10 and 20 gram vials as well. Drug Store News (2/21) Email this Story
  • Pluristem gets orphan drug designation for PLacental eXpanded cells
    Pluristem Therapeutics' PLacental eXpanded cells have been designated an orphan-disease treatment by the FDA as a therapy for aplastic anemia. "Receiving orphan drug designation for aplastic anemia is an important event for Pluristem as it open pathways for using our PLX cells for additional indications in the field of hematology," said Zami Aberman, Pluristem's chairman and CEO. Globes (Israel) (2/21) Email this Story
  • China issues new quality standards for drug distribution
    China's State Food and Drug Administration has issued new quality-control standards for drug distributors and retailers that cover record keeping, cold-chain management and transportation. The new regulations take effect in June but allow a three-year transition period for related drug enterprises. Xinhuanet.com (China) (2/19) Email this Story
  Food & Dietary Supplements 
  Medical Devices 
  Tobacco 
  • Deyton leaves top post at FDA's tobacco center
    FDA Commissioner Dr. Margaret Hamburg announced the departure of Dr. Lawrence Deyton as director of the FDA Center for Tobacco Products effective on March 4. Under Deyton's leadership, the CTP has collaborated on the state level, enacted limits on tobacco production and advertising, and established the scientific basis required for tobacco regulation, Hamburg said. Deyton will become a professor at George Washington University and will be replaced at the CTP by Mitchell Zeller. Forbes (2/21), The Washington Post/The Associated Press (2/22) Email this Story
  FDLI Items 
  • Registration now open: FDLI's Intro to Medical Device Law and Intro to Drug Law -- April 3-4
      
    Hear from experts who will review the essential elements of Food and Drug Administration regulation in a systematic and comprehensive way during these separate two-day interactive programs. Whether you are a new professional in the medical device or drug industry, or seasoned regulatory affairs professional needing a refresher, you will benefit from one of these courses. Register today and save $100. Email this Story

  • Don't miss the 2013 Annual Conference -- Get the Early Bird rate until March 1
     
    FDLI's Annual Conference is the largest and longest-running legal conference for FDA-regulated industry and the entire food and drug law community. This advanced two-day program will cover legal, regulatory, policy and economic issues spanning the gamut of FDA's authority by bringing together experts from the federal government, industry, public sector, consulting organizations and academia. Register now and save $300. Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

 
Position TitleCompany NameLocation
Project Manager, Drug Safety and InnovationThe Pew Charitable TrustsWashington, DC
Advertising and Promotions CounselPrinceton Legal Search Group, LLCWashington, D.C., DC
FDA AssociateK&L GatesMultiple Locations, United States
Counsel II, Legal (Anti-corruption)Gilead SciencesFoster City, CA
Click here to view more job listings.

  SmartQuote 
The question should be, is it worth trying to do, not can it be done."
--Allard Lowenstein,
American politician


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