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November 2, 2012News for the food and drug law community

  Drugs & Biologics 
  • J&J settles 845 suits tied to antibiotic Levaquin
    Johnson & Johnson settled around 845 lawsuits accusing the drugmaker of not properly warning consumers against the tendon damage risks tied to antibiotic Levaquin, according to a federal court filing in Minneapolis. More than 3,400 federal and state lawsuits have been filed alleging tendon injuries from Levaquin, the filing said. "As part of reaching a settlement agreement, the parties are also working toward developing a standardized settlement protocol through which plaintiffs will submit cases for an evaluation of whether, and to what extent, their cases are compensable," J&J and the plaintiffs said. Bloomberg Businessweek (11/1) Email this Story
  • New view at FDA gets treatments to patients faster
    Changes in oncologists' treatment expectations, greater influence and advocacy from patients and scientific discoveries fundamentally changed how the FDA reviews cancer drugs, writes Dr. Patricia Keegan, director of the Division of Oncology Products 2 in the agency's Office of Hematology and Oncology Products. Doctors care less about whether a drug shrinks a tumor than its ability to extend life or prevent metastasis, and independent experts urged the FDA to approve drugs sooner, based on a single efficacy study, she writes. The agency now approves cancer drugs faster so patients can benefit sooner, as exemplified in the area of drugs to treat metastatic cancer, Keegan writes. FDA Voice blog (10/31) Email this Story
  • Pay-to-delay case works its way toward the Supreme Court
    Courts have held differing opinions on the legality of pay-to-delay deals drugmakers make with competitors to stave off generic competition. The 3rd U.S. Circuit Court of Appeals reversed a trend toward upholding the agreements as legal, making it more likely that the Supreme Court will decide the issue, attorney Erica J. Hemphill Kraus writes. The New England Journal of Medicine (subscription required) (11/1) Email this Story
  • FDA finds bacteria in batches of NECC's injection steroid, heart drug
    The FDA found various types of bacteria in three separate recalled batches of the New England Compounding Center's preservative-free injection steroid betamethasone and in one batch of the NECC-supplied heart surgery drug cardioplegia. The findings "reinforce the FDA's concern about the lack of sterility in products produced at NECC's compounding facility," the agency said. Reuters (11/1) Email this Story
  • Mass. implements stricter oversight of drug compounders
    Massachusetts will use new rules to improve oversight of compounding pharmacies. The regulations give the state authority to monitor the distribution and volume of drugs that compounders sell to identify if they are operating like drugmakers. Reuters (11/1) Email this Story
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  Global Focus 
  Food & Dietary Supplements 
  Medical Devices 
  • FDA issues guidance on 510(k) goals for FY 2013 to 2017
    The FDA has released guidance outlining its performance objectives and time frames for the 510(k) clearance process for medical devices in fiscal years 2013 to 2017. The goals, meant to address concerns that the 510(k) process has lagged or become too complex, include shrinking the average time for clearance decisions from 150 days in FY 2012 to 124 days in FY 2017. (Boston) (10/29) Email this Story
  FDLI Items 
  • Confirmed speakers for Food Advertising: Claims, Litigation and Strategies – Nov. 15
    On Nov. 15 in New York City, FDLI is hosting a food advertising-focused program in cooperation with the New York State Bar Association. Just confirmed speakers:
    • Mary Johnson, senior attorney, Division of Advertising Practices, FTC
    • Brian O’Malley, president and CEO, Domino Foods
    • Stephen Gardner, director of litigation, Center for Science in the Public Interest
    View the detailed agenda on our website, and make sure to register before Nov. 8 to take advantage of early-bird promotional pricing -- Save $100! Email this Story
  • Introduction to Drug Law & Regulation -- register now -- Nov. 13-14
    Throughout the last 20 years, FDLI's industry standard two-day drug law course has helped thousands think like an experienced professional. This first offering since the passage of the Food and Drug Administration Safety and Innovation Act ("FDASIA") includes updated content, making participation important for more than just beginners. During this updated, introductory level course, experts will review the essential elements of FDA drug regulation systematically and comprehensively. From the definition of "drug" to the different regulatory schemes for over-the-counter (OTC) and prescription (Rx) drugs, this course addresses key regulations and policies. Speakers will provide a broad overview of the FDA regulatory structure, the history of drug regulation, detail on specific areas such as the approval process, and a review of how FDA enforces and implements the laws passed by Congress. Registration now open. Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

Position TitleCompany NameLocation
FDA Regulatory AssociateArnold & Porter LLPWashington, DC
Regulatory Counsel, GlobalConfidentialNorthern, NJ
Senior Counsel - Regulatory and Quality Assurance ComplianceThe Procter & Gamble CompanyCincinnati, OH
Health & FDA Business AssociateGreenberg TraurigWashington, DC
Click here to view more job listings.

  Editor's Note 
  • Correction
    The subject line in Thursday's FDLI SmartBrief contained a typo. It should have read, "FDA re-examines extended-release generics." SmartBrief regrets the error. Email this Story
Be daring, be different, be impractical, be anything that will assert integrity of purpose and imaginative vision against the play-it-safers, the creatures of the commonplace, the slaves of the ordinary."
--Cecil Beaton,
British photographer and costume designer

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