On September 19, 2011, the U.S. Food and Drug Administration (FDA) published its Guidance document entitled “Marketed Unapproved Drugs – Compliance Policy Guide.” Found here, the document details the widespread availability of unapproved drugs on the market and explains the Agency’s priorities with respect to enforcement. Because of the large volume of these drugs on the market and the FDA’s limited resources, the Agency is forced to prioritize how it will exercise its enforcement discretion. Setting forth its highest priorities, the FDA intends to continue targeting unapproved drugs that pose significant health risks to consumers.

On September 30, 2011, the U.S. Food and Drug Administration (FDA) announced the release of its draft guidance, entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The Guidance comes as a part of the FDA’s overhaul of its medical device review scheme, as the FDA intends to implement to streamline the way medical devices are reviewed and cleared. As previously reported, the FDA announced its plans to overhaul its entire system for reviewing and clearing medical devices earlier in 2011 and highlighted its intentions to target the “de novo” review process as a means to lessen the burden for manufacturers, while continuing its mission of public safety.