| December 2, 2008 | News for the biotech, medical device, drug and food regulatory profession |
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- Concerns arise about studies conducted overseas
Western drugmakers and regulators are under mounting pressure to ensure the safety of clinical trials conducted in developing countries after reports of death and complications in participants. Some experts are concerned about possible violations of clinical-testing rules, while others worry that companies may be taking advantage of individuals desperate to join studies. Drugmakers said they follow the rules when conducting trials abroad, including securing government authorization and routinely inspecting sites. The Wall Street Journal
(12/1)  
- Medicis settles patent rift with Impax over acne drug
Medicis Pharmaceutical Corp. will grant licensing rights for a generic formulation of Solodyn, an acne medication, to Impax Laboratories as part of an agreement that settles a patent dispute between the companies. The deal also includes a joint-development pact for an advanced version of Solodyn and four other dermatology treatments. Bloomberg
(12/1)
- FDA staff: Coartem safe, effective against malaria
Coartem, a malaria treatment from Novartis AG, is safe and effective, according to an FDA staff review online. FDA advisers plan to meet Wednesday to evaluate whether to recommend approval for the decade-old drug, which is already cleared in 83 countries. Bloomberg
(12/1)
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| | Thought-Provoking Interviews with Medical Device Industry Leaders.
Tap into strategic viewpoints of industry pioneers and read candid insights from experienced leaders in the medical device industry! These in-depth, one-on-one interviews with luminaries across the med-tech industry offer insightful perspectives on where the industry is heading. Courtesy of Medical Device Daily – Click here now for FREE access. | |
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| Biotechnology |  |  |
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- Researchers identify genes that affect degree of illness
An Australian study involving 300 people found that about 28% had certain gene combinations that made them more vulnerable to serious symptoms or prolonged bouts of illness, while 18% had a genetic profile that enabled them to recover quickly. The results could be used to develop more personalized therapies for common infectious ailments and to identify those who require priority treatment in case of a pandemic, the lead researcher said. The Telegraph (London)
(12/1)
- Cellectis unveils gene-research tool
Cellectis SA has introduced a gene-research kit designed to help scientists develop stable cell clones faster and more accurately than with existing technologies. Some drugmakers and biotech firms in Europe have purchased the tool, which features 10 experiment tubes containing hamster cells, a Cellectis executive said. The French company hopes to expand the product's range to include cells of mice, humans and other species. The Guardian (London)/Reuters
(12/1)
| Food & Dietary Ingredients | | |
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- Consumer Reports finds high levels of sodium in cereals, bagels
A Consumer Reports magazine analysis of 37 food products found a cup of Kellogg's Raisin Bran contains 350 milligrams of sodium and a Pepperidge Farm Whole Grain White Bagel carried 440 milligrams. U.S. dietary guidelines recommend no more than 2,300 milligrams of sodium a day for healthy adults, though most Americans get far more than that. Reuters
(12/1)
| Medical Devices | | |
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- CMS urged to consider outcomes of cardiac CT angiography
 The CMS should take into account clinical evidence in deciding whether to offer widespread coverage for cardiac CT angiography, according to an editorial in The New England Journal of Medicine. The authors argued that the use of heart imaging continues to climb by 26% yearly even though there is insufficient proof of its benefit to patients. HealthImaging.com
(12/1)
| FDLI Items | | |
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Last chance to register and appear on the attendee list! "The Regulation of Controlled Substances and Diversion Control" conference, Dec. 4 and 5; Receive CLEs
Prescription drug abuse is a growing problem in the U.S., as are the related risks and liabilities for manufacturers, wholesalers, distributors and pharmacies for failure to secure adequate packaging and safe distribution channels. How can patients, who have legitimate medical conditions, obtain drug therapies that contain controlled substances, without being hindered by controls intended to minimize diversion? How is REMS impacting controlled substances? This conference will explore how DEA and FDA seek to balance the need to ensure the availability of medicines while reducing the risk of diversion and abuse. Learn more. Register online. Register by fax.
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Call for Sessions: FDLI's 52nd Annual Conference, April 22 and 23, 2009
You are invited to submit a proposal for a 1.5 hour, concurrent session scheduled during FDLI's Annual Conference in Washington, D.C. The theme for this Annual Conference is, "Opportunities and Challenges Facing FDA and New Administration." Your submission is to include a title, 2-3 sentence description and proposed participants. Submit your proposal to smg@fdli.org no later than Dec. 19, using the subject line: Call for Sessions. Proposal submission does not guarantee selection. FDLI will review submissions and consider how proposed sessions complement the Annual Conference. You will be notified if your session has been selected.
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