FDA Related News

Medical Devices

Multiple Violations in BD Inspection

FDA warns Becton Dickinson about multiple violations at its San Diego facility that manufactures the Pyxis Medication Management System.

Clinical Investigation Protocol Deviations

FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.

Medical Devices

Updated POLARx Instructions is Class 1 Recall: FDA

FDA says a Boston Scientific recall updating instructions for two cryoablation balloon catheters is Class 1.

Human Drugs

FDA Seeks Comments on ODAC Briefing Guidance

FDA says it will receive comments until 2/28 on a draft guidance on the possibility for cancer drug sponsors and FDA to prepare a joint briefing docum...

Human Drugs

CGMP Violations in Akorn Formulations Review

FDA warns Akorn Formulations in Hyderabad, Telangana, India, about CGMP violations in its production of over-the-counter drugs for the U.S. market.

FDA General

Temple Retires; Bumpus Leaves FDA

CDER senior advisor for clinical science Bob Temple retires, and FDA principal deputy commissioner Namandj Bumpus leaves the agency ahead of the new i...

Biologics

Xbrane Refiles Lucentis Biosimilar BLA

Xbrane Biopharma refiles a BLA for its investigational ranibizumab, a biosimilar copy of Genentechs age-related macular degeneration drug Lucentis.

Medical Devices

Alert on AquaFlexFlow Blood Circuits

FDA issues a safety alert on Nuwellis AquaFlexFlow UF 500 Plus extracorporeal blood circuit because the device may trigger a weight mismatch alarm whi...

Human Drugs

Senators Introduce Skinny Label Generic Drug Bill

Four senators introduce bipartisan legislation to protect generic drug manufacturers from innovator drug lawsuits over skinny labeled generics.

Human Drugs

ICH M15 Model-Informed Drug Development Principles

FDA publishes an International Council for Harmonization draft M15 guidance on model-informed drug development principles.