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JOBS Act Update
Last year on April 5th, President Obama signed the JOBS Act into law with a requirement that SEC implement regulations and a web portal process to stimulate crowdfunding by January 1, 2013. Well, we...
Still Here, Will the 2.3% Medical Device Excise Tax Ever Go Away
I had the pleasure of receiving several emails, links, and assorted RSS feeds letting me know that the Senate passed a budget and the Medical Device Excise Tax was voted out. Unfortunately, this tidbit...
Abbott gets nailed for off-label promotion
Abbott got nailed for its off-label promotion of drug Depakote this May. The $1.5B settlement covers civil, criminal, and administrative charges, but the settlement still leaves the door open for prosecutors to come after Abbott management...
Wrongfully Accused Copyright Infringement
There seems to be no way to even slow the massive intellectual property piracy on the internet. Recently, Congress introduced the Stop Online Piracy Act (SOPA) legislation. This is really just the tip of...
REDUCED MEDICARE REGULATORY BURDENS ON HEALTH CARE PROVIDERS WILL SAVE OVER $5 BILLION
Press Release- May 10, 2012, the Centers for Medicare & Medicaid Services (CMS) finalized two rules today to reduce unnecessary, obsolete, and/or burdensome regulations on American hospitals and health care providers. These rules will...
FDA and HHS refuse to implement Section 6004 of the Affordabale Care Act
Section 6004 of the Affordable Care Act requires manufacturers and authorized distributors of record to submit very specific information on recipients of free drug samples to FDA annually beginning April 1, 2012. FDA issued draft guidance announcing that it...
Creative Funding Website Kickstarter.com
I recently ran across an interesting website www.kickstarter.com. When I forwarded the link to small list of friends, coleagues, and clients I got lots of positive feedback. One example came from a long time...
FDA’s early feasibility study IDE applications
FDA has announced new draft guidance for early feasibility study IDE applications, a completely new clinical approval mechanism for FDA. Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health says,...
Obtaining a Patent
U.S. Patent and Trademark Office grants a monopoly on the use and development of an invention. The costs of filing and maintaining a patent in the United States are not trivial. The experience of...
Definition of Intellectual Property
Defined as the ownership of ideas, unlike assets, IP is a collection of ideas and concepts.Intellectual property is defined as the ownership of ideas. Unlike tangible assets to your business such as computers or...
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