Clarus asks FDA for written guidance on safety and efficacy standards needed for approval of an application for oral testosterone-ester prodrugs.
FDA issues Aurobindo a Form-483 after an inspection last month at the firms Unit 7 manufacturing facility in Telangana, India.
The Institute for Clinical and Economic Review identifies nine drugs whose 2017-2018 price increases were not supported by evidence of additional clin...
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...