| March 13, 2012 | News for the biotech, medical device, drug and food regulatory profession |
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| Drugs & Biologics |  |  |
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- FDA outlines 45-day review period before TV ads air
Drugmakers should submit proposed direct-to-consumer television ads to the FDA Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research for review before airing them, according to a draft guidance from the agency. The FDA has 45 days from the date a complete package is received for review and will notify the sponsor if the review will not be completed on time. "This guidance creates an FDA 'shot clock' that doesn't allow you to take a shot at broadcast marketing for an additional 45 days," said Coalition for Healthcare Communication Executive Director John Kamp. Medical Marketing & Media
(3/12)  
- FDA panel backs continued study of newer targeted painkillers
An FDA advisory committee unanimously agreed that trials of investigational anti-nerve growth factors should continue, saying the drug class could prove beneficial for pain sufferers with limited treatment options. Johnson & Johnson, Pfizer and Regeneron Pharmaceuticals were testing such drugs for low back pain or osteoarthritis. The drugmakers should find a way to identify patients likely to benefit from treatment and
those predisposed to joint damage, FDA advisers said. Reuters
(3/12)
- FDA approves Organogenesis' cell-based product for gum surgery
Organogenesis has received FDA approval to market Gintuit, its cell-based product designed to replace receding gum tissue during dental gum surgeries. Gintuit is composed of donated skin cells attached to bovine collagen. Organogenesis CEO Geoff MacKay said the decision marks the agency's first approval of a mass-produced cell treatment and its first OK of regenerative tissue for an oral condition. The Boston Globe (tiered subscription model)
(3/9)
| Food & Dietary Supplements | | |
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- Legislators want FDA to require labels on GM foods
Fifty-five members of Congress signed a letter to FDA Commissioner Margaret Hamburg, saying the agency's labeling policy is inadequate because it does not cover food technologies such as genetic engineering that elicit changes not detectable by human senses.
"We urge you to fully review the facts, law, and science, and side with the American public by requiring the labeling of genetically engineered foods as is done in nearly 50 countries around the world," the letter states. FoodSafetyNews.com
(3/13)
| Medical Devices | | |
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- Consumer Reports email slams device approvals
An email from Consumer Reports President Jim Guest took aim at the FDA's fast-track 510(k) process for authorizing medical devices.
"This isn't science fiction ... the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were 'similar' to products already on the market," Guest wrote. Consumers Union, the magazine's advocacy arm,
began a campaign in late 2011 to change the way devices are approved. Reuters
(3/12)
 | FDLI’s Annual Conference – April 24-25 in Washington, DC.
Don’t miss the largest and longest-running legal conference for regulated industry. Hear directly from FDA leadership, including Commissioner Hamburg; advance your career; and engage in hot topic sessions: regulatory science, international developments, innovation and social media. Register Today! |
| FDLI Items | | |
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Complimentary FDLI & RAPS luncheon for members only -- March 27, Washington, D.C.
FDLI is partnering with the Regulatory Affairs Professional Society to host a complimentary members-only luncheon. FDLI and RAPS members are invited to join us on March 27 for a luncheon presentation that focuses on collaboration, When Legal and Regulatory Departments Collaborate -- Success Stories. Representatives from the legal and regulatory departments of device manufacturer Medtronic and pharmaceutical manufacturer AstraZeneca will talk about their success working as a team. Attend this luncheon to learn from experienced legal and regulatory affairs professionals and gain insight into the effectiveness and efficiency of their collaboration. E-mail FDLI's Customer Service Department if you would like to register for this complimentary event.
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Is it a drug, dietary supplement or food? Why does it matter?
Find out during the functional foods session at FDLI's 2012 Annual Conference. With increased scrutiny from regulatory bodies as well as the continued drive of private litigation, keeping informed on the complex relationship among food, dietary supplements and drugs is more important than ever. Learn about these issues at FDLI's 55th Annual Conference at our "functional foods" session. Save $200 through March 23.
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| Position Title | Company Name | Location |
| Senior Counsel - Regulatory and Quality Assurance Compliance | Procter & Gamble | Cincinnati, OH |
| Senior Corporate Attorney (Regulatory) | Astellas Pharma | Deerfield, IL |
| Senior Counsel, Research | GE Healthcare | Wauwatosa, WI |
| Manager/Associate Director US Regulatory Affairs | Pfizer | Madison, NJ |
| IP Counsel | Novo Nordisk | Princeton, NJ |
| Regulatory Scientist | Morgan, Lewis & Bockius LLP | Washington, DC |
| Corporate Counsel/Senior Corporate Counsel | Genentech | South San Francisco, CA |
| Regulatory Affairs Leader | BD (Becton, Dickinson and Company) | Franklin Lakes, NJ |
| Senior and Principal P/T Consultants | Becker & Associates Consulting | Nationwide, United States |
| Regional Compliance Lead - AfME | Pfizer, Inc. | Dubai, United Arab Emirates |
| Healthcare / Food & Drug Associate | Arnall Golden Gregory LLP | Washington, DC, DC |
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