| November 7, 2012 | News for the food and drug law community |
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| Drugs & Biologics |  |  |
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- FDA flags cardiovascular risks tied to Novo's degludec
The FDA highlighted uncertain heart risks tied to Novo Nordisk's long-acting insulin degludec. The drug could raise by 10% the risk of unstable angina, nonfatal stroke, nonfatal heart attack and cardiovascular death, according to the initial assessment of an analysis of 16 studies. The added risk was found to be higher at 30% in a later update. Reuters
(11/6)  
- Pfizer's arthritis drug Xeljanz wins FDA approval
The FDA approved Pfizer's Xeljanz, or tofacitinib, to treat patients with moderate to severe rheumatoid arthritis who can't tolerate methotrexate or for whom it is ineffective. The approval makes Xeljanz the first rheumatoid arthritis drug from a new class of pain treatments known as JAK inhibitors. Yahoo/The Associated Press
(11/6)
- Congress issues subpoena to hear NECC chief pharmacist
The House of Representatives Energy and Commerce Committee subpoenaed New England Compounding Center co-owner and chief pharmacist Barry Cadden to appear at a hearing on a deadly meningitis outbreak linked to contaminated drugs. "With more than 400 people infected and 30 deaths, it is critical that we hear directly from the head of the facility linked to the outbreak," according to a statement from committee chairman Fred Upton and ranking member Henry Waxman. "Since Mr. Cadden has indicated he will not appear voluntarily, we are left with no choice but to issue a subpoena." Reuters
(11/6), The Washington Times/The Associated Press
(11/6)
- Oversight of drug compounders didn't improve after 2002 outbreak
Little has changed in the regulation and oversight of compounding pharmacies since a 2002 meningitis outbreak was tied to a drug made by a South Carolina pharmacy, an event similar to the current outbreak linked to Massachusetts' New England Compounding Center, said Jeffrey Engel, an epidemiologist who investigated the 2002 incident. Drugstores' mass production of high-risk treatments continues in many states, according to this article. The Washington Post
(11/5)
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| Medical Devices | | |
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- Paragonix seeks 510(k) clearance for cardiac transport device
Paragonix Technologies has filed an application with the FDA seeking 510(k) clearance for the Sherpa Pak Cardiac Transport System. The disposable device, which is used to store donor hearts in transit, releases oxygenated blood to organs and is designed to extend the preservation time for donor hearts from the current four hours to 12 hours. Mass High Tech (Boston)
(11/6)
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| FDLI Items | | |
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Get first-hand knowledge from first U.S.-based veterinary stem cell company
Hear from Dr. Bob Harman, founder and CEO of Vet-Stem, the first U.S.-based commercial veterinary stem cell company at FDLI's Regenerative Medicine: Key Developments in Regulation & Commercialization conference on Nov. 29 in Washington, D.C., and San Francisco. Dr. Harman is currently the CEO and principal clinical development director of the programs at Vet-Stem. Previously he was the CEO of HTI-Bio-Services, a preclinical research company for veterinary and human pharmaceutical development. He has authored more than 500 contract study reports for animal health companies throughout the world and for submission to the FDA and USDA in support of the development of new animal and human health products. Don't miss the opportunity to hear Dr. Harman discuss the business of regenerative medicine.
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New Primer: Medical Device Review Process: A Focus on Pre-Market Requirements
This brand new Primer walks readers through the process of determining whether a product qualifies as a medical device, describes the various FDA premarket requirements, and details the numerous pathways for bringing a medical device to market, including 510(k) applications, Premarket Approval Applications (PMAs), Investigational Device Exemptions, Humanitarian Device Exemptions, and Custom Devices. Get instant access, download now.
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