| December 27, 2012 | News for the food and drug law community |
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| Drugs & Biologics |  |  |
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- FDA issues guidance to expedite drug development
The FDA has released a draft guidance document designed to help drug companies speed development. The 42-page guidance outlines "enrichment strategies" meant to improve the efficiency of drug trials such as excluding patients unlikely to demonstrate clinical benefit. "These are potentially powerful strategies for the pharmaceutical industry because appropriate use of enrichment could result in smaller studies, shortened drug development times, and lower development costs," wrote Dr. Bob Temple of the FDA. MedPage Today (free registration)
(12/26)  
- Patients are winners in ruling on unapproved uses of drugs
 The 2nd U.S. Circuit Court of Appeals' ruling that truthful communications between a physician and a drug company representative are protected speech under the First Amendment is a victory for patients, PhRMA General Counsel Mit Spears writes. Using drugs in ways that the FDA has not approved is valuable and even can be the standard of care. Ensuring timely and robust communications between health care professionals and biopharmaceutical firms is important as the focus increases on using the best possible therapies and controlling costs. Milwaukee Journal Sentinel (tiered subscription model)
(12/26)
- AMAG seeks expanded FDA approval for anemia drug Feraheme
AMAG Pharmaceuticals filed a supplemental new drug application with the FDA seeking approval to market injectable Feraheme, or ferumoxytol, to patients with iron deficiency anemia who don't respond to or can't take oral iron therapy. The filing was based on the results of an international, late-stage program, which had more than 1,400 participants. RTT News
(12/24)
- Japan clears Bristol-Pfizer blood thinner Eliquis
Pfizer and Bristol-Myers Squibb obtained approval from Japanese regulators to market the anticoagulant Eliquis, or apixaban, for ischemic stroke and systemic embolism prevention in patients with nonvalvular atrial fibrillation. The approval was based on positive results of the late-stage ARISTOTLE trial. Eliquis has also been approved in Europe and Canada. Pharmaceutical Business Review Online
(12/27)
| Food & Dietary Supplements | | |
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- Wis. court postpones raw milk case trial
A Sauk County, Wis., court has postponed the trial of Vernon Hershberger on charges related to the sale of unpasteurized milk. Hershberger said in briefs filed by his lawyer that he could not assist in his defense due to his religious beliefs. A conference regarding the motion is set for Jan. 4. FoodSafetyNews.com
(12/27)
| Medical Devices | | |
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| FDLI Items | | |
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Introduction to Food Law and Regulation -- Feb. 5-6, Washington, D.C.
For a new professional in the field, understanding the numerous food law issues and requirements can be a daunting task. FDLI's industry standard course, Introduction to Food Law and Regulation, is a one-stop resource that provides the basics of food law and regulation. This comprehensive two-day program on the essential elements of food law and regulation, taking place during Food Week 2013, is valuable for new members of the legal community, government officials, advertising, marketing and investment professionals, and others new to the food and dietary supplement community. This conference is also an excellent refresher for the seasoned professional. Learn more about Food Week 2013.
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Global Developments: What's Your GPS? Conference -- Food Week 2013, Feb. 8
Participants in FDLI's Global Developments conference during Food Week 2013 will hear robust discussion of significant international developments affecting global food stakeholders, including the increasingly complex global food supply chain, expanding access to global markets and Food Safety Modernization Act mandates requiring foreign food facilities to register with FDA. Join us to learn about the critical issues that will affect your business and clients through country and regional case studies, including Brazil and China. Learn more about Food Week 2013.
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| Position Title | Company Name | Location |
| Associate Director Regulatory Affairs - Advertising, Promotion & Labeling | Shire | Lexington, MA |
| Assistant Commissioner for Compliance Policy | Food and Drug Administration | Silver Spring, MD |
| Associate Commissioner for Regulatory Affairs | Food and Drug Administration | Silver Spring, MD |
| Assistant Commissioner for Compliance Policy | Food and Drug Adminstration | Silver Spring, MD |
| Senior Counsel – Medical Device/Combination Product | Amgen | Thousand Oaks, CA |
| Counsel, Advertising and Promotions | Mylan Pharmaceuticals Inc. | Basking Ridge, NJ |
| Sr. Manager, Regulatory Affairs-Promotional Review | Novo Nordisk | Princeton, NJ |
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