A Hyman, Phelps & McNamara medical device regulatory expert and attorney say FDA needs to improve the timeliness of its posting of de novo decision su...
ICU Medical expands a Class 1 recall of its Plum 360, Plum A+ and Plum A+3 Infusion Systems to update the use instructions due to a manufacturing defe...
FDA grants ReAlta Life Sciences orphan drug and fast track designations for RLS-0071 and its use in treating hospitalized patients with steroid-refrac...
Federal Register notice: FDA determines that Horizon Therapeutics Pennsaid (diclofenac sodium) topical solution 2% was not withdrawn due to safety or ...
Federal Register notice: FDA makes available a final guidance entitled Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA....
FDA approves a Johnson & Johnson BLA for Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of certain adult patient...
FDA clears a SI-Bone 510(k) for the iFuse Torq TNT Implant System for pelvic fragility fracture fixation and sacroiliac joint fusion.
CDRH grants a de novo marketing authorization for SoCleans 3+ Bacterial Reduction Device, an over-the-counter product intended to be used as an adjunc...
