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Medical Devices

Becton Dickinson Recalls Blood Collection Tubes

Becton Dickinson recalls its BD Vacutainer Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers due to a chemical in the sto...

Federal Register

Antimicrobial Drugs Panel Meeting on Achaogen NDA

Federal Register notice: FDA announces a 5/2 Antimicrobial Drugs Advisory Committee meeting on an Achaogen NDA for plazomicin.

Medical Devices

FDA Clears Auris Health Monarch Platform

FDA clears an Auris Health 510(k) for the Monarch Platform to assist with diagnostic and therapeutic bronchoscopic procedures for treating lung cancer...

Medical Devices

FDA Clears Delta Meds Closed System Catheter

FDA clears a Delta Med 510(k) for the DeltaVen Closed System Catheter.

Human Drugs

AbbVie Scraps Accelerated Approval for Lung Cancer Therapy

AbbVie decides to not seek accelerated approval for Rova-T (rovalpituzumab tesirine) as a third-line treatment for relapsed/refractory small cell lung...

Federal Register

CBER Science Symposium Planned for June

Federal Register notice: FDA announces a 6/25-26 public symposium entitled 2018 Center for Biologics Evaluation and Research Science Symposium.

Federal Register

Several Information Collections Approved by OMB

Federal Register notice: FDA announces OMB approval of several information collections.

Human Drugs

House Passes Right-to-Try Bill

The House passes a right-to-try bill that would allow terminally ill patients access in certain circumstances to experimental therapies.

Human Drugs

FDA Analyses Help Guide Opioid Policy: Gottlieb

FDA commissioner Scott Gottlieb tells a House subcommittee that agency post-marketing analyses are helping inform opioid policy.

Medical Devices

Monteris Medical Recalls NeuroBlate System

FDA announces a Monteris Medical Class 1 recall of its NeuroBlate system and associated laser delivery probes.