Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide recommendations on the design ...
FDA issues Elevar Therapeutics and its Chinese partner, Jiangsu Hengrui Pharmaceuticals, a complete response letter for their combination rivoceranib ...
FDA clears an Implicity 510(k) for its algorithm SignalHF used in its remote monitoring for heart failure.
Representatives Raul Ruiz (D-CA) and Larry Bucshon (R-IN) introduce bipartisan legislation to improve participation in clinical trials by underreprese...
FDA clears a Brainomix 510(k) for its Brainomix 360 e-Lung for lung imaging.
FDA grants Notal Vision a de novo authorization for its patient self-operated SCANLY Home optical coherence tomography device.
Federal Register notice: FDA announces the issuance of emergency use authorizations (EUAs) for certain medical devices related to Covid-19.
FDA publishes 32 new and revised product-specific guidances to aid in development of generic drugs and a revised list of PSGs under development.
