FDA Related News

Human Drugs

FDA Lists 6 OMB-approved Info Collections

Federal Register notice: FDA announces that six information collections that have been approved by OMB.

Human Drugs

Novartis Gene Therapy Facility Approved by FDA

FDA gives commercial licensure approval to a second Novartis gene therapy manufacturing facility, this one in Durham, NC.

FDA Participating in EHR Integration Project

FDA participates in the OneSource electronic health record data integration project.

Human Drugs

Sotrovimab No Longer Authorized Anywhere

FDA says GlaxoSmithKlines sotrovimab is now not authorized for use in any HHS region because the proportion of Covid-19 cases from the omicron BA.2 su...

Human Drugs

CDER Head Looks to Improved Drug Safety Surveillance

CDER director Patrizia Cavazzoni outlines budget priorities for FY 2023, including a priority to improve drug postmarket surveillance and oversight of...

Medical Devices

FDA Approves GE Automatic Anesthesia Software

FDA approves a GE Healthcare PMA for its End-tidal (Et) Control software for general anesthesia delivery on its Aisys CS2Anesthesia Delivery System.

Human Drugs

FDA to Rate Drug Firms Quality Management Maturity

A new FDA whitepaper outlines the agencys plans to advance a framework to objectively rate pharmaceutical manufacturing sites Quality Management Matur...

Human Drugs

Priority Review for Dupixent sBLA

FDA grants priority review for Sanofi and Regenerons sBLA for a new Dupixent indication.

Human Drugs

CGMP Issues at NDAL Mfg.

FDA warns Monterey, CA-based NDAL Mfg. that it is manufacturing unapproved new drugs with CGMP violations.

Human Drugs

Comments on FDA Immunogenicity Information Guidance

AstraZeneca and Janssen comment on an FDA draft guidance on immunogenicity information in drug product labeling.