Reading this on a mobile device? Try our optimized mobile version here:

January 15, 2013News for the food and drug law community

  Drugs & Biologics 
  • Why the FDA's focus on breakthrough meds is good news
    The pharmaceutical industry's focus will shift toward more groundbreaking, innovative medicines because of the Breakthrough Therapy Designation, the FDA's new regulatory incentive structure, Luke Timmerman writes. The emphasis on breakthrough drugs, together with the high number of drug approvals last year, is a positive development for drugmakers and patients, he writes. Xconomy (1/14) Email this Story
  • GSK seeks approval for diabetes drug Albiglutide
    GlaxoSmithKline has filed for FDA approval for albiglutide, its once-weekly diabetes drug. Albiglutide is an injectable GLP-1 drug and belongs to the same class as Novo Nordisk's Victoza and Bristol-Myers Squibb's and AstraZeneca's Byetta and Bydureon. Reuters (1/14) Email this Story
  • EU expands approval of Janssen-Cilag's prostate cancer drug Zytiga
    The European Commission approved the use of Janssen-Cilag's Zytiga, or abiraterone acetate, in combination with prednisolone or prednisone, for patients with metastatic castration-resistant prostate cancer who do not respond to androgen deprivation and for whom chemotherapy is not indicated. The drug's approval in the U.S. was expanded recently to include men with metastatic castration-resistant prostate cancer before chemotherapy. PharmaTimes (U.K.) (1/14) 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.
  Global Focus 
  • Compulsory licenses in India could be setback for drugmakers
    Multinational drugmakers are concerned as India moves toward issuing compulsory licenses for three patented cancer treatments. "There has to be an interactive dialogue between the government and multinational pharma companies regarding the price difference," said Organisation of Pharmaceutical Producers of India president Ranjit Shahani. In March, PhRMA CEO John J. Castellani said that "CLs cannot solve India's larger problems regarding access to medicines and health care." Business Standard (India) (1/15) Email this Story
  Food & Dietary Supplements 
  • European agency publishes data on Monsanto's biotech corn
    The European Food Safety Authority has made all data on Monsanto's biotech corn NK603 available to the public online as part of the agency's commitment to "further enhance transparency in its decision-making processes." The move "will make the conclusions of risk assessments even stronger when ensuring public health protection and further build confidence in EFSA's work," EFSA official Catherine Geslain-Laneelle said. Fox Business/Dow Jones Newswires (1/14), FoodNavigator (1/14) Email this Story
  Medical Devices 
  • FDA warns St. Jude over manufacturing practices at Calif. plant
    The FDA has issued a warning letter to St. Jude Medical over manufacturing practice violations at its facility in Sylmar, Calif. St. Jude "will continue manufacturing and shipping product from the Sylmar facility and customer orders are not expected to be impacted while we work to resolve the FDA's concerns," according to a company filing. Bloomberg Businessweek (1/14) Email this Story
  • Russia reportedly adopts changes to medtech regulatory process
    Authorities in Russia reportedly have issued revised rules governing the regulation of medical technologies in that country. Rozsdravnadzor, the country's medtech regulator, said the new rules went into effect Jan. 1. The rules, which are being analyzed by Emergo Group, potentially include new permits for importing testing samples, clinical testing rules and expert device evaluation. (Boston) (1/11) Email this Story
  • Bangladesh launches "Death Clock" to discourage tobacco use
    Bangladeshi Information Minister Hasanul Haq Inu introduced a "Death Clock" to attract policymakers' attention and win public support against tobacco use. The clock tallies the number of people dying of tobacco-related diseases in the country, which is among the world's leaders in use of tobacco. Bangladesh is considering increases in tobacco taxes and restrictions on use. Reuters (1/13) Email this Story
  FDLI Items 
  • Pharmacy compounding -- Join the discussion on Feb. 12
    With newly proposed legislation, the courts split, and statutory authority at issue, this is the ideal time for stakeholders to convene, communicate, and explore "what's next" in compounding oversight. Join FDLI for our upcoming program -- Pharmacy Compounding: An FDLI Dialogue -- on Feb. 12 in Washington, D.C. In an open, balanced format, experts will discuss and debate the regulation of pharmacy compounding, providing a historical framework and exploring recent developments. Participants will delve into key questions about policy, surveillance and enforcement, legislative and oversight issues. Discussion will address unresolved questions related to defining "compounding" and "manufacturing," as well as how the courts and Congress have interpreted FDA's authority and role in regulating pharmacy compounding. Email this Story

  • Medical Device Compliance, Regulation and Litigation Conference -- March 4
    At this conference, now in its second year, attendees will hear top officials from FDA's Center for Devices and Radiological Health (CDRH) discuss in detail the most significant recent, and upcoming, medical device compliance, regulatory and enforcement actions. Legal experts will analyze the most important cases of 2012 and detail what to expect in 2013 in litigation and regulatory developments, including key products liability issues. In addition, this conference will explore hot topics in medical device regulation and policy, including: document and data retention; the 510(k) clearance process; Unique Device Identifiers, electronic mobile applications, and the widespread use of social media to communicate with end-users. Register now and save $100. Email this Story

Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

Position TitleCompany NameLocation
Senior Counsel – Medical Device/Combination ProductAmgenThousand Oaks, CA
Compliance Counsel - PrivacyOtsukaPrinceton, NJ
Corporate AttorneyOtsukaRockville, MD
Corporate AttorneyOtsukaPrinceton, NJ
Counsel, Advertising and PromotionsMylan Pharmaceuticals Inc.Basking Ridge, NJ
Regulatory ConsultantThe Weinberg GroupWashington, DC
Click here to view more job listings.

If any man will draw up his case, and put his name at the foot of the first page, I will give him an immediate reply. Where he compels me to turn over the sheet, he must wait my leisure."
--John Montagu,
British statesman

Email this Story

Subscriber Tools
Print friendly format | Web version | Search past news | Archive | Privacy policy

Account Director:  Meryl Harold (202) 407-7828
Job Board:  Jackie Basso (202) 407-7871
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