| November 29, 2012 | News for the food and drug law community |
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- J&J's tuberculosis drug gets FDA panel support
An FDA panel has backed the safety and efficacy of Johnson & Johnson's bedaquiline drug for tuberculosis, but also pointed out possible heart and liver-safety issues. The drug works by targeting the adenosine triphosphate synthase enzyme, which the pathogen requires to generate energy. Reuters
(11/28)  
- Civil suits against NECC may proceed, judge rules
U.S. District Judge Dennis Saylor allowed civil lawsuits to proceed against the New England Compounding Center, the compounding pharmacy tied to a nationwide meningitis outbreak. Criminal cases would have priority in collecting evidence, Saylor said. Reuters
(11/28)
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- EU regulators OK insulin delivery system from CeQur
European regulators have granted CeQur CE mark approval to market its device designed to replace daily insulin injections in type 2 diabetes patients. The device, which can administer insulin consistently for three days, is targeted for a limited European release next year and a broader launch in 2014. Mass High Tech (Boston)
(11/27)
- Indian patent board upholds ruling against AstraZeneca
India's Intellectual Property Appellate Board dismissed AstraZeneca's challenge to a ruling that negated the drugmaker's patent on a quinazoline derivative. The ruling is similar to other recent rulings in the country voiding drugmaker patents. Reuters
(11/28)
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| Medical Devices | | |
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- Senate is urged to repeal device tax as part of fiscal cliff deal
More than 800 firms and health care groups have sent a letter asking the Senate to repeal the 2.3% medical device tax set to begin in January as part of fiscal cliff negotiations. The letter noted that the medtech sector provides more than 400,000 jobs nationwide and invests almost $10 billion annually in research and development. AdvaMed CEO Stephen Ubl also said in a statement that the tax "will only lead to fewer jobs, reduced investment in tomorrow's treatments and cures, or higher health care costs for the consumer." Fox Business
(11/28)
- AFrame's mobile monitoring device gains FDA clearance
The FDA has given AFrame Digital 510(k) clearance to market MobileCare Monitor in the U.S. as a Class II medical device. The device, which is akin to a wristwatch, is designed to continuously monitor gait and detect falls among the elderly and other vulnerable patients, and transmit that data in real time to a caregiver's personal device using Bluetooth. MobiHealthNews.com
(11/28)
- FDA streamlines medical device guidance with new website
How the FDA publishes and asks for feedback on the guidance documents crafted by the Center for Devices & Radiological Health will be simplified thanks to the agency's new medical device guidance website. Industry stakeholders can use the website to post suggestions, recommend draft language and submit input on which topics to prioritize for guidance next year. MassDevice.com (Boston)
(11/27)
| FDLI Items | | |
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Early-bird ends tomorrow: Register for Enforcement, Litigation, and Compliance Conference
Whether you are a regulator, litigator, compliance specialist or consultant, it is critical to stay current on the changing trends in enforcement, litigation, and compliance. This two-day conference will thoroughly examine the changes in law and regulation in the last year and analyze trends and changes in the year ahead. This conference is unique in its scope -- covering all FDA- regulated areas -- allowing attendees to benefit from a birds-eye view of compliance trends across industries. Don't miss this Dec. 12-13 conference. Register.
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Network at FDLI's Annual Holiday & Leadership Awards Reception -- Dec. 12
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.
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| Position Title | Company Name | Location |
| director quality assurance, Regulatory - Seattle, WA | Starbucks | Seattle, WA |
| Sr. Director, Regulatory Affairs | Confidential | Bucks County, PA |
| Senior Corporate Counsel | Medivation | San Francisco, CA |
| PCH Planning & Reporting Mgr | Pfizer inc. | Manila, Philippines |
| Regulatory Counsel | Becton Dickinson | Franklin Lakes, NJ |
| Sr. Brand Attorney | Novo Nordisk | Princeton, NJ |
| Assistant Counsel, Regulatory Attorney | MERCK & COMPANY INC. | North Wales, PA |
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