| December 11, 2012 | News for the food and drug law community |
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| Drugs & Biologics |  |  |
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- FDA expands approval for J&J's Zytiga drug
Johnson & Johnson received expanded FDA approval for its Zytiga drug to be used prior to chemotherapy treatment in patients with advanced prostate cancer. Zytiga was first approved in 2011. The therapy is used to reduce testosterone production. Reuters
(12/10)  
- Opinion: FDA demands drive up drug development costs
The FDA's consistent demands for more tests and bigger clinical trials are driving increased costs for pharmaceutical research and development, according to this opinion piece. The FDA isn't responsible for making sure drug companies make profits, and neither should it be pushing innovation toward financial impossibility, the writers argue. The Examiner (Washington, D.C.)
(12/6)
- FDA moves deadline of GDUFA self-identification process to Dec. 18
The FDA extended the mandatory self-identification process under the Generic Drug User Fee Amendment to Dec. 18 as more than 17,000 manufacturing facilities worldwide still haven't acted. The extension allows the industry to "clarify issues for the right implementation of the guidelines," said Kaushik Desai, former president of the Indian Pharmaceutical Association's Industrial Pharmacy Division. PharmaBiz.com (India)
(12/11)
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| Food & Dietary Supplements | | |
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| Medical Devices | | |
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- Ethicon unit's surgical sealant patch gains FDA approval
The FDA has granted Ethicon Biosurgery, an Ethicon unit, approval for its EVARREST system designed to help control problematic, surgery-related bleeding. The fibrin sealant patch, which is used with manual compression, has been approved as an ancillary tool to hemostasis for soft tissue bleeding in patients undergoing pelvic surgery and other procedures. BeckersASC.com
(12/10)
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- Panel calls for docs to talk to youth about smoking cessation
The U.S. Preventive Services Task Force has issued draft guidelines urging physicians to counsel youth on the consequences of smoking and on ways to withstand pressures to smoke. The panel also advised the doctors to refer children and teens who use cigarettes to smoking-cessation counseling programs. Reuters
(12/10)
| FDLI Items | | |
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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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This week -- Register for Enforcement, Litigation and Compliance Conference -- Dec. 12-13
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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| Position Title | Company Name | Location |
| Associate Director Regulatory Affairs - Advertising, Promotion & Labeling | Shire | Lexington, MA |
| Sr. Director, Regulatory Affairs | Confidential | Bucks County, PA |
| director quality assurance, Regulatory - Seattle, WA | Starbucks | Seattle, WA |
| Senior Corporate Counsel | Medivation | San Francisco, CA |
| Assistant Counsel, Regulatory Attorney | MERCK & COMPANY INC. | North Wales, PA |
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| Click here to view more job listings. |
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- Tuesday, December 04, 2012
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