Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Device Reporting 21 CFR Part 803 (OMB Control Num...
FDA grants Lumenis a de novo authorization for its newest intense pulsed light device for improving signs of dry eye disease.
A Government Accountability Office analysis says prices for 20 major prescription drugs were higher in the U.S. than in three other countries.
FDA clears a Soliton special 510(k) for modifications to its Resonic device and its use for tattoo removal and cellulite treatment.
Academic medical center researchers document gaps in demographic representation for older adults and black patients in cancer therapeutic pre- and pos...
Federal Register notice: FDA seeks comments on an information collection extension entitled Electronic User Fee Payment Request Forms Form FDA 3913 a...
Pew Charitable Trusts calls on HHS to reinstate FDAs authority to require premarket reviews for laboratory-developed tests.
FDA says it is working with manufacturers of transmucosal immediate-release fentanyl products to ease provider and pharmacy recertification in a modif...