Medac Pharma gains FDA approval for Rasuvo | FDA clears new dosage for pain management patch | Pozen's stroke-heart drug accepted for review by FDA
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July 17, 2014
FDLI SmartBrief
News for the food and drug law community

Drugs & Biologics
Medac Pharma gains FDA approval for Rasuvo
The FDA has granted Medac Pharma approval for its Rasuvo subcutaneous injection for the treatment of rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis and psoriasis. Medscape (free registration) (7/16) Share: Email
FDA clears new dosage for pain management patch
Purdue Pharma obtained expanded approval for a new 7.5 mcg/hour dosage strength of its Butrans pain management patch. Pharmaceutical Processing (7/16) Share: Email
Pozen's stroke-heart drug accepted for review by FDA
The FDA has agreed to review Pozen's resubmission of a marketing application for its experimental drug, a combination of aspirin and omeprazole, for the prevention of heart attack and stroke. A decision is expected by Dec. 30. The News & Observer (Raleigh, N.C.)/.Biz blog (7/16) Share: Email
FDA lifts partial clinical hold on Concert Pharma's spasticity drug
The FDA has removed its partial clinical hold on Concert Pharmaceuticals' experimental spasticity drug CTP-354, clearing the way for the drug's midstage trials. The firm plans to test the drug in a daily dose of 12 milligrams by September. American City Business Journals/Boston/BioFlash blog/Mass High Tech (7/16) Share: Email
Don't revisit ruling on 340B dispute, HHS asks court
A federal judge is being asked by HHS not to re-examine a decision he issued in May in a lawsuit filed by the Pharmaceutical Research and Manufacturers of America over whether the Obama administration exceeded its authority by forcing drugmakers to give 340B orphan drug discounts for nonorphan conditions. Officials are allowed under the ruling to issue the same policy again but in a different form, HHS said. The judge is being urged by drugmakers to make clear that the ruling bars that policy. Modern Healthcare (free registration)/Vital Signs blog (7/16) Share: Email
Food & Dietary Supplements
Kessler: Stronger food-label changes needed
Proposed changes in U.S. packaged-food labels may not help curb obesity and influence consumers' food choices, former FDA Commissioner David Kessler wrote in The New England Journal of Medicine. Kessler suggested stronger measures, such as more-comprehensible ingredient lists and indicating calorie counts in bold on the front of packages. Reuters (7/16) Share: Email
Undeclared allergens trigger recall of pops from King of Pops
Key lime pie pops and banana pudding pops were pulled by King of Pops because they include wheat, egg, soy and milk not indicated on the labels. The affected products, sold in Charleston, S.C., bear the UPC codes 59959 00304 and 59959 00305. Food Poisoning Bulletin (7/16) Share: Email
Medical Devices
DorsaVi's activity-monitoring device lands FDA clearance
The FDA has cleared dorsaVi to market its ViMove system for use in clinical settings or athletic training. The technology uses sensors to monitor muscle activity and movement, and wirelessly sends those readings to a computer for evaluation by physicians. (7/16) Share: Email
FDA clears IBA's compact gantry for proton therapy device
Ion Beam Applications has been cleared by the FDA to market its Compact Gantry Beam Line, which will be integrated with the company's ProteusOne device used for single-room proton therapy. (free registration) (7/16) Share: Email
Strict antismoking policies may reduce risk of suicide
In states that have higher cigarette taxes and tougher smoking bans in public spaces, the number of people committing suicide dropped up to 15%, compared to the national average, according to a study in the journal Nicotine & Tobacco Research. Lower taxes and mild antismoking rules were associated with an increase in suicides by up to 6%. HealthDay News (7/16) Share: Email
FDLI Items
Get CLE ethics credit: Complying with the FCPA -- An FDLI Webinar, July 29
This webinar will help legal and compliance professionals ensure they are up-to-date on Foreign Corrupt Practices Act provisions and the lessons learned from recent high-profile cases. The webinar will discuss when an FCPA investigation is necessary; risks and benefits of self-reporting; recent government enforcement actions and takeaways from FCPA and anti-corruption cases. Register today. Share: Email
Save the date: Enforcement, Litigation, and Compliance Conference PLUS holiday reception, Dec. 8-9
FDLI's annual Enforcement, Litigation, and Compliance conference will be held on Dec. 8-9 at the Renaissance Hotel Downtown in Washington, D.C. The heads of the Offices of Compliance for all six of the FDA's enforcement centers have been invited. FDLI's Holiday Reception will immediately follow the conference on Dec. 8 from 5:30 p.m. - 7:00 p.m. For more information or to participate in this conference, please contact Laura Brown at Share: Email
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Biotechnology/Pharmaceutical Patent AttorneyCoats and Bennett PLLCCary, NC
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