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 FDA issued draft guidance announcing that it would delay enforcement until at least
FDA has announced new draft guidance for early feasibility study IDE applications, a completely new clinical approval mechanism for FDA.