A One Day Intensive Seminar Designed to Drill Down into the Practical Application and Nuances American Conference Institute’s Conference on: The AMP Final Rule Click here to learn more
By Dan Packel, Originally published on Law 360 Pennsylvania plaintiffs should not draw too much hope from the state’s Supreme Court declining to address a lower court ruling that product liability claimsfrom users of generic Reglan weren’t necessarily preempted by federal law, as rulings in other venues have not been kind to claimants… [ Read More ]
Pharma & Healthcare – the latest on the FDA move towards the way it approves OTC meds, Walgreens, UnitedHealth, and more to share patient date and more. Steering for a U.S. comeback, AstraZeneca’s Brilinta runs aground on DoJ investigation by Tracy Staton Published on Fierce Pharma Marketing Here’s a scenario: You’re trying to jump-start sales of…
Pharma & Healthcare – the latest on the FDA and Xarelto, TPG and Chindex’s deal and more. No FDA love for Xarelto in ACS patients by Carly Helfand Published on FiercePharma Looks like the FDA has taken an advisory committee’s Xarelto concerns to heart. Following up on an overwhelming “no” vote from last month, the agency Friday issued Johnson &…
Pharma & Healthcare – the latest on medical product development, Sanofi’s Lemtrada drug, FDA approval and more. Preparing for a “New Era of Medical Product Development” by Eitan Bernstein, Carolyne Hathaway, John Manthei Published on jdsupra.com FDA report demonstrates support for personalized medicine and more efficient regulatory pathways. In a new report issued by the Food and Drug Administration…
Pharma & Healthcare – the latest on J& J probe, Roche to develop superbug killer and more. J&J to pay $2.2b in pharma kickback probe – source by Reuters on NBCNews Pharmaceutical giant Johnson & Johnson will pay $2.2 billion to the U.S. government to end civil and criminal investigations into kickbacks to pharmacists and the…
When: Thursday, January 16 to Friday, January 17, 2014 Where: The Washington Plaza Hotel, Washington D.C To Learn More, Visit: http://americanconference.com/controlledsubstances Live Industry News Follow @ACI_Pharma Join ACI’s Pharmaceutical /Biotech / Life Sciences Experts Group Industry News U.S. Recommends Tighter Control on Hydrocodone Pain Pills by Anna Edney & Elizabeth Lopatto Posted on Bloomberg.com Vicodin and other…
Press Release from FDA, Released on 09/20/2013 Today, the U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices. The UDI system has the potential to improve the quality of information in medical device adverse events reports, which…
Pharma & Healthcare – the latest on DEA probe, False Claims Act, Pfizer and more. Costco says cooperating with DEA probe on controlled substances by Jessica Wohl Editing by Leslie Adler and Bob Burgdorfer Posted on Reuters Costco Wholesale Corp (COST.O) said on Wednesday that it will cooperate with the U.S. Drug Enforcement Administration in its ongoing…
Expert Guest Blog Entry by Brian Dahl, Originally Posted on ProPharmaGroup Big pharma and their deep pockets have been the focus of enforcement activities for a number of years but in 2013 that tide may be turning. In the past few months, settlements with ISTA Pharmaceuticals, TranS1/Baxano Surgical, and others have sent a clear message that…
To read the complete article click on the title. Medical-device tax repeal is an idea full of holes Posted on WP Opinions by Editorial Board F THE Capitol Hill impasse ever ends, it will probably be through a compromise under which House Republicans abandon their demands to delay or defundObamacare — in return for a concession Senate…
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