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February 21, 2013News for the food and drug law community

  Drugs & Biologics 
  • FDA: Codeine use after tonsillectomy can be fatal to children
    The FDA issued a warning Wednesday against the use of codeine-containing drugs to ease pain in children who have had their tonsils or adenoids removed, following 13 reports of child deaths linked to the drug. Since many of these children had sleep apnea, "they may have been particularly sensitive to the breathing difficulties that can result when codeine is converted in the body to high levels of morphine," officials said. The agency said it will require all codeine-containing products to have a boxed warning against use in children after such surgeries. The Wall Street Journal (2/20) Email this Story
  • Fla. House panel approves anti-biosimilars bill
    A Florida House subcommittee approved a bill that would require pharmacists to alert prescribing doctors when they substitute a biosimilar drug for a brand-name biologic drug and to keep records of biosimilar substitutions for four or more years. Opponents, including pharmacy benefit managers, pharmacists and some drugmakers, say the bill would stifle innovation, deny patients needed care and keep drug costs high. Sarasota Herald-Tribune (Fla.) (2/19) Email this Story
7 keys: Put real-world evidence into action
Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
  Food & Dietary Supplements 
  Medical Devices 
  • Sanitas' outpatient management system gets FDA OK
    The FDA has approved Sanitas' Wellaho mobile technology platform as a Class II medical device for patients with chronic diseases. The personalized outpatient management device is designed to help chronically ill patients keep track of their conditions, as well as enable doctors to monitor them and oversee their treatment between office visits. San Diego Business Journal (2/20) Email this Story
  • Senator to consult industry on pay-for to advance device tax repeal
    Amid renewed efforts in the Senate and House to strike down the 2.3% medical device tax, Sen. Elizabeth Warren, D-Mass., plans to consult with the industry about how to make up for the revenue that would be lost if the tax is repealed. "I want to talk to the industry so they understand my basic position, and that is we should never increase taxes on the manufacturing that we're trying to develop in this country," she said. (Boston) (2/19) Email this Story
  FDLI Items 
  • Registration now open: Controlled Substances Regulation, March 28 in Washington
    Join us for this one-day conference that will focus on significant developments in FDA's and DEA's regulation of controlled substances. The program brings together government, industry and public interest experts to provide updates on the latest regulations and legislation affecting controlled substances' stakeholders. Participants will discuss key developments after passage of the Food and Drug Administration Safety and Innovation Act; important scheduling and rescheduling situations from the past year; and enforcement updates. The program will also feature a roundtable on the recently issued draft guidance on abuse-deterrent opioids, featuring FDA participation and a diverse group of industry and public interest representatives. Panelists will engage attendees in interactive dialogue on current hot topics and ongoing legal and policy decisions. Register by Feb. 28 to get the early bird rate. Email this Story

  • Learn baseline requirements for marketing medical products in Brazil
    FDLI is pleased to provide Brazilian Drug and Medical Device Regulation: A Practical Guide as a companion product to our September 2012 conference, U.S. & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device, and Food Law and Regulation. This Practical Guide, written by experienced lawyers and regulatory specialists, provides summaries of Brazil's requirements for the development, approval and marketing of drugs and medical devices. This Guide also includes English translations of many relevant laws and directives. It is intended to help you to take advantage of various marketing pathways and enable successful partnerships in Brazil. Preview now. Email this Story
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Position TitleCompany NameLocation
Project Manager, Drug Safety and InnovationThe Pew Charitable TrustsWashington, DC
Advertising and Promotions CounselPrinceton Legal Search Group, LLCWashington, D.C., DC
Counsel II, Legal (Anti-corruption)Gilead SciencesFoster City, CA
FDA AssociateK&L GatesMultiple Locations, United States
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The psychic task which a person can and must set for himself is not to feel secure, but to be able to tolerate insecurity."
--Erich Fromm,
German psychologist

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