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...
A Chamber of Commerce survey shows that patients taking prescription drugs can stop taking their medications in response to ads promoting lawsuits aga...
FDA opens a public docket to receive comments on drug continuous manufacturing.
FDA commissioner Scott Gottlieb announces a public meeting to hear input on ways that the agency can eliminate problems in approval of generic drugs.
Rep. Morgan Griffith introduces legislation to preserve patient access to compounded drugs.
Sen. Charles Grassley asks FDA commissioner Scott Gottlieb to support legislation to increase access to and lower the price of drugs.