CDER issues a MAPP on how Office of New Drugs reviewers are to handle the review and management of financial disclosure submitted in NDAs, BLAs, and t...
FDA clears a K2M Group Holdings 510(k) for its Mojave PL 3D Expandable Interbody System, a 3D-printed expandable posterior-lumbar interbody system.
CDER publishes a MAPP on Office of Generic Drugs review of borquivalence studies with clinical endpoints.
Merit Medical Systems gains de novo clearance from FDA to expand the indication for its Embosphere Microspheres to now include prostatic artery emboli...
FDA approves LivaNovas VNS Therapy systems for expanded MRI labeling, allowing patients to visit any MRI center in the U.S. and have access to more th...
Federal Register notice: FDA seeks comments on an information collection extension for Application for Participation in FDA Fellowship Programs.
Stakeholders support FDAs plan to create an Office of Patient Affairs and ask for clarifications and changes in its possible structure and operations....
Two Shook, Hardy & Bacon attorneys say that new Supreme Court justice Neil Gorsuch is likely to favor textualism in the courts ongoing debate over fed...