CDRHer Michelle Tarver says FDA is participating in two collaborative communities and wants to be in 10 by the end of 2020.
FDA clears a UVision360 510(k) for the 3mm Luminelle Dx 360 Rotatable Disposable Sheath, an attachment for the Luminelle DTx Hysteroscopy System.
Public Citizen petitions FDA and the Drug Enforcement Administration to up-classify Tramadol and similar drugs from Schedule 4 to Schedule 2 under the...
CBER issues a SOPP on regulatory meetings under some user fee programs.
GlaxoSmithKline asks FDA to look at four categories of information that have been raised in litigation over Zofran pregnancy labeling and determine wh...
FDA clears a Vyaire Medical 510(k) for the bellavista 1000e ventilator.
CBER posts Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS).
Federal Register notice: FDA posts a list of eight information collections that have been approved by OMB.