Federal Register notice: FDA requests public comments on a new information collection related to a proposed Experimental Study on Warning Statements f...
The 3rd Circuit Appeals Court sends hundreds of plaintiffs claims against Mercks Fosamax back to a district court because the claims are not preempted...
As Congress and president Trump pledge to address skyrocketing drug costs, a new report by consumer advocacy group Public Citizen calls into question ...
A new report by Pew Charitable Trusts says that currently available data on antibiotic use in the U.S. are insufficient.
Senate Health, Education, Labor & Pension committee chair Lamar Alexander (R-TN) says a confirmation hearing will be scheduled soon after the committe...
FDA approves an iCAD PMA for its PowerLook Tomo Detection device, a concurrent-read computer aided detection product for digital breast 3D tomosynthes...
FDA denies an Osmotica Pharmaceutical petition asking the agency to require that any ANDA seeking approval of venlafaxine HCl extended-release tablets...
FDA denies a 10/2016 Sandoz citizen petition that asked FDA not to approve generic copies of GlaxoSmithKlines asthma inhaler Advair Diskus 100/50 (flu...