Federal Register
Info Collection on Device Risk Allegations
Federal Register notice: FDA seeks comments on an information collection entitled Electronic Submission Process for Voluntary Allegations to the Cente...
Human Drugs
Janssen sBLA for Darzalex Combination Use for Myeloma
FDA accepts for review a Janssen Pharmaceutical supplemental BLA for Darzalex (daratumumab) for use in combination with Amgens Kyprolis (carfilzomib) ...
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 2/7/2020.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Draft Guide on sBLA for Biosimilar Use
Federal Register notice: FDA announces a draft guidance entitled Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions ...
Federal Register
Info Collection Extension for PMA Devices
Federal Register notice: FDA sends to OMB an information collection extension for Premarket Approval of Medical Devices.
Medical Devices
GE Recalls Carestation Anesthesia Systems
GE Healthcare recalls the Carestation 600 Series Anesthesia Systems because there is a potential for a loose cable connection which could cause the de...
Human Drugs
Workshop on Multi-Component Biomarkers
FDA announces a 3/23 public workshop on multi-component biomarker concepts and terminology.
Federal Register
HIV Resistance Assay Put in Class 2
Federal Register notice: FDA classifies human immunodeficiency virus drug resistance genotyping assays using next generation sequencing technology int...
Biologics
Senators Query FDA on Coronavirus Resources, Shortages
Two U.S. senators ask FDA whether it has the necessary resources to ensure active pharmaceutical ingredients and other medical products and food impor...
