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 if they fail to comply with
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 the iceberg. When Congress fails to
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 help achieve the key goal of
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 FDA issued draft guidance announcing that it would delay enforcement until at least
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 friend, Frederick Jeng, Esq., where his
FDA has announced new draft guidance for early feasibility study IDE applications, a completely new clinical approval mechanism for FDA.
U.S. Patent and Trademark Office grants a monopoly on the use and development of an invention.
Defined as the ownership of ideas, unlike assets, IP is a collection of ideas and concepts.