Food and Drug Administration (FDA)

By Kate Greenwood
In Biologics and Biosimilars
Nov 17th, 2014
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By Jordan Paradise The Biosimilars Price Competition and Innovation Act of 2009 (BPCIA) introduced a long-awaited, and highly-supported, abbreviated route to market for “biosimilar” and “interchangeable” biologic products. The goal was to create incentives for development and reduce health care costs in the same way that previous legislation had accomplished in the gen...
By Kate Greenwood
In Drugs & Devices
Nov 6th, 2014
1 Comment
By Nicole Stuver Three-dimensional scanning, modeling, and printing have become an emerging field of diagnosing and treating maladies.  This technology has enabled advances in neurology, dentistry, orthodontics, orthopedics, cardiology, oncology and other fields of practice.  These new technologies are revolutionary particularly because they have the capability to be c...
By Kate Greenwood
In Drugs & Devices
Oct 2nd, 2014
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Cross-Posted at Bill of Health Earlier this week, the Food and Drug Administration announced that it was reopening the comment periods for the two draft guidances on the use of social media to promote prescription drugs and medical devices that it released in June:  Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Informatio...
By Kate Greenwood
In Drugs & Devices
Sep 2nd, 2014
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Last week, Seton Hall Law alum David Gibbons of Hyman, Phelps & McNamara published a blog post at the firm’s FDA Law Blog on a very interesting legal question, whether a court can order the FDA to order a drug manufacturer to recall a drug. In a suit brought by Hospira challenging the FDA’s approval of […]...
By Carl Coleman
In Bioethics
Aug 13th, 2014
5 Comments
The Ebola outbreak, which has claimed nearly 1,000 lives since its emergence in West Africa in December 2013, has brought renewed attention to policies surrounding the “compassionate use” of unapproved medications – i.e., the provision of unapproved medications to individuals outside the context of clinical trials.   The issue rose to the forefront early last week [&he...