FDA makes available a draft guidance entitled Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredient...
FDA grants Roivios a breakthrough device designation for its JuxtaFlow Renal Assist Device and its use in safeguarding kidney function for patients un...
FDA approves a Medtronic PMA for the Inceptiv closed-loop rechargeable spinal cord stimulator for treating chronic pain.
InfuTronix recalls its Nimbus infusion pump systems due to multiple potential failure modes that may include battery failure, upstream blockage (occlu...
FDA clears an Expanse ICE 510(k) for the ICE Aspiration System for use in peripheral thrombectomy procedures.
FDA grants fast track designation to Compass CTX-009 that is in a Phase 2 study with paclitaxel to treat some biliary tract tumors.
FDA publishes a draft guidance to help sponsors expand eligibility for cancer drug clinical trials in terms of washout periods and concomitant medicat...
Federal Register notice: FDA announces that OMB has approved an information collection entitled Electronic Records: Electronic Signatures.
