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FDA allows marketing of first ZnT8Ab autoantibody test to help diagnose type 1 diabetes

Today, the U.S. Food and Drug Administration allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and... read more

FDA approves new drug to treat a form of Gaucher disease

The U.S. Food and Drug Administration today approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder.

Turkish man pleads guilty to importing illegal cancer drugs

Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.

FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer

The U.S. Food and Drug Administration today approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.

Food and Drug Adminstration (FDA): CDRHNew

Cereberal Spinal Fluid (CSF) Shunt Systems

Placement of cerebral spinal fluid (CSF) shunt systems to treat hydrocephalus is a common medical procedure and a life-saving treatment for many patients. These shunt systems drain excess fluid from... read more

Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 940KB)

This document provides guidance on the study and evaluation of sex-specific data in medical device clinical studies. The purpose of this guidance is to outline the FDA?s expectations regarding... read more

FDA Voice Blog: Clinical Trials: Enhancing Data Quality, Encouraging Participation and Improving Transparency

Today FDA is announcing important steps that the agency plans to take to enhance the collection and availability of clinical trial data on demographic subgroups ? patient populations divided by sex,... read more

Public Workshop - Brain-Computer Interface Devices for Patients with Paralysis and Amputation, November 21, 2014

The purpose of this workshop is to obtain feedback on scientific, clinical, and regulatory considerations associated with BCI devices. Ideas and suggestions generated during this workshop may facilitate development of... read more

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Urgent Medical Device Recall / Field Safety Notice - Micro SSP DNA Typing Trays

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