FDA Related News

Medical Devices

Vascular Solutions Recalls Venture Catheter

Vascular Solutions begins a recall of its Venture catheter because there is a risk of the catheter tip splitting or separating during use.

Human Drugs

FDA Advisors Support Victoza sNDA

FDA advisors say trial data indicate that Victoza 1.8 mg injection reduces cardiovascular risk in patients with Type 2 diabetes.

Human Drugs

FDA/EMA Pilot Program Aims to Harmonize Inspections

An ongoing FDA/European Medicines Agency pilot program on good clinical practice inspections shows promising results that could lead to greater harmon...

Human Drugs

Critics Question Trump Drug Price Control Plan

The New York Times reports that critics say that some aspects of a draft administration executive order on drug prices could increase prices rather th...

Human Drugs

Growing Industry Interest in Emerging Technologies: CDER

CDER Office of Testing and Research director Lucinda Buhse tells a Drug Information Association session that the agency has seen growing drug industry...

Federal Register

Public Workshop Planned for Tuberculosis Treatments

Federal Register notice: FDA announces a 7/19 public workshop on scientific and clinical trial design considerations for developing new tuberculosis t...

Medical Devices

FDA Approves VNS Therapy Systems for Expanded MRI Scans

FDA approves LivaNovas VNS Therapy systems for expanded MRI labeling, allowing patients to visit any MRI center in the U.S. and have access to more th...

Federal Register

Comments Sought on FDA Fellowship Applications

Federal Register notice: FDA seeks comments on an information collection extension for Application for Participation in FDA Fellowship Programs.

Support for FDA Patient Engagement Plans

Stakeholders support FDAs plan to create an Office of Patient Affairs and ask for clarifications and changes in its possible structure and operations....

Gorsuch Likely to Maintain Preemption Jurisprudence: Lawyers

Two Shook, Hardy & Bacon attorneys say that new Supreme Court justice Neil Gorsuch is likely to favor textualism in the courts ongoing debate over fed...