The recent controversy surrounding a study of newborn babies in universities across the United States demonstrates the importance of compliance with human subject protection regulations in medical research....more
Last week, President Obama announced a new research initiative designed to advance our understanding of the human brain. It is hoped that the new initiative, dubbed the BRAIN (Brain Research through Advancing Innovative...more
Traumatic brain injuries can manifest themselves in a vast array of symptoms. Victims can be made to struggle with any combinations of memory difficulties, motor difficulties, personality changes and emotional struggles....more
The Omnibus Rule went into effect on March 26, 2013. While covered entities and business associates have until Sept. 23, 2013, to comply with new restrictions and obligations, they can take advantage of the rule’s benefits...more
Big Pharma and academia cement big deals in the quest for bigger prizes -
With the patents of many highly profitable blockbuster drugs expiring over the course of a few years, the search is on for new drugs to fill...more
Originally published in WP Thompson & Co. on March 4, 2013.
On 26 February 2013, the UK government announced a proposed change to the Patents Act to exempt clinical and field trials, as well as "health technology...more
The Final Rule implementing the Physician Payment Sunshine Act was announced on February 1st and published in the Federal Register on February 8th. The Final Rule establishes procedures for drug and device manufacturers to...more
On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more
On Friday, February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) released the highly anticipated final rule to implement the federal Physician Payments Sunshine Act (the “Sunshine Act”). The final rule will...more
In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more
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