Federal Register notice: FDA submits to OMB a new information collection conflict of interest information for non-employee fellowship programs partici...
Akin Gump attorneys highlight provisions in a package of six guidances issued by FDA to clarify its position on software exemptions under the 21st Cen...
Federal Register notice: FDA seeks consumer organizations interested in participating in selecting voting and nonvoting consumer representatives to se...
Public Citizen calls on FDA to order Amags Makena off the market because it is ineffective at reducing the rate of some pre-term births.
FDA warns Herbal Healer Academy about multiple violations of the Federal Food, Drug, and Cosmetic Act involving many of its homeopathic drugs and diet...
FDA awards $4.1 million to fund two new research grants for natural history studies in rare diseases to help design efficient clinical trials.
FDA classifies as Class 1 a Medtronic recall of its 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material separating from the d...
Stakeholders generally praise a revised ICH guideline on clinical studies and suggest changes.