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December 7, 2012News for the food and drug law community

  Drugs & Biologics 
  • FDA expresses confidence in reviews of generic drugs
    The FDA's approval process for generic drugs, including approvals based on extrapolated data, is safe and reliable, Center for Drug Evaluation and Research Director Dr. Janet Woodcock and other FDA officials wrote in an article in the New England Journal of Medicine. The agency withdrew approval for 300-mg bupropion after finding it did not perform similarly to the brand-name version of the same dose. The drug was approved based on extrapolation of bioequivalence data from the 150-mg dose. Medscape (free registration) (12/5) Email this Story
  • PET drugmakers have 3 years to secure approvals
    The FDA has released guidelines for PET drug manufacturers, establishing a December 2015 deadline for approvals through new drug applications, abbreviated new drug applications or investigational new drug applications for PET drugs being used in the clinical setting. The guidelines include recommendations on the steps companies should take in submitting applications and the required safety data. (free registration) (12/6) Email this Story
  • Letter raises concerns over compliance with FDA rules
    The FDA slapped Shanghai Huhui Daily Use Chemical Products with a warning letter for several violations, including redacting production records. These moves "raise serious concerns regarding the integrity, reliability and traceability of the data generated and documented in your batch production records," the FDA said in the letter. Blog (12/6) Email this Story
  • Mass. takes action against 3 more pharmacies
    The Massachusetts Department of Public Health ordered the temporary shutdown of Oncomed Pharmaceuticals and the partial shutdowns of Whittier Pharmacist and Pallimed Solutions as part of its crackdown following a deadly meningitis outbreak tied to the New England Compounding Center. The department expressed concerns over the handling and preparation of several treatments. DPH spokesman David Kibbe said the pharmacies are working with regulators and are anticipated to reopen as soon as the concerns are addressed. Reuters (12/6) Email this Story
  Food & Dietary Supplements 
  • GAP sues FDA for not disclosing data on food animal antibiotics
    The Government Accountability Project sued the FDA alleging that the agency's decision to "withhold agency data regarding the sale of antibiotics for use in food animals" is against the law. GAP filed a Freedom of Information Act request that sought information regarding the amount of food animal antibiotics sold in 2009. (12/6) Email this Story
  Medical Devices 
  • Iridex lands 510(k) clearance for laser delivery device
    The FDA has cleared Iridex to market its TxCell system for laser delivery. The technology, which allows for the laser to be administered in a multi-spot scanning fashion, is intended to cut the time it takes for doctors to perform various laser photocoagulation procedures. (12/6) Email this Story
  FDLI Items 
  • Due today: Submit a proposal for a session at FDLI Annual Conference
    FDLI will host its 56th Annual Conference on April 23-24 in Washington, D.C. This event, attended by a large and diverse cross-section of food and drug law professionals, has risen to prominence throughout almost six decades because of the contributions from the food and drug law community. We invite you to submit a proposal for a general or breakout session. Submit your proposal online no later than today. Proposal submission does not guarantee selection. Email this Story

  • RSVP today to attend FDLI's Annual Holiday and Leadership Awards Reception
    Each year the Food and Drug Law Institute recognizes up to four individuals from various areas of the food and drug law community for their notable service and leadership to receive the Distinguished Service and Leadership Award. FDLI members attend the Annual Holiday and Leadership Awards Reception where the recipients are recognized. The Dec. 12 reception will be held 5:30-7 p.m. at The Westin Georgetown in Washington, D.C. FDLI members: Register Online. Not a member of FDLI? To join us, e-mail Lauren Roberts, FDLI's membership manager. She will register you, and share information about the benefits of joining the Institute. Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

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Freedom lies in being bold."
--Robert Frost,
American poet

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