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
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 FDA issued draft guidance announcing that it would delay enforcement until at least
FDA has announced new draft guidance for early feasibility study IDE applications, a completely new clinical approval mechanism for FDA.