FDA Provides Guidance on Use of Electronic Health Data, Pooled Data in Postmarketing Studies

A new guidance document released by US federal regulators aims to establish best practices for conducting and reporting pharmacoepidemiologic safety studies that are conducted using electronic healthcare data, such as those maintained by insurance companies, hospitals and other healthcare providers.  The final guidance document, Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data, was released on 14 May 2013 by the US Food and Drug Administration (FDA).  In it, the agency makes a number of specific recommendations regarding the design, analysis and results of such studies done in support of protocols and reports that are submitted to FDA, such as a clinical study done to support a drug or biologic application.

Interview: FDA’s UDI Architect Jay Crowley on the Agency’s Approach to UDI and Pending Changes

The US Food and Drug Administration (FDA) is, like many device regulatory bodies around the world, preparing to implement a huge overhaul of its medical device systems. Known as the Unique Device Identification (UDI) rule, the US regulator wants to build a system that allows for safer, more accountable medical devices.  But that process, which is global in scale, is not without significant challenges. In the wake of a flurry of UDI activity in recent weeks, we called up FDA’s Jay Crowley, senior adviser for patient safety at the Center for Devices and Radiological Health (CDRH) and the regulator responsible for FDA’s UDI effort, to talk about the philosophy and status of the UDI program, as well as what comes next for regulators and industry.

New FDA-Approved Device Offers Promise Of Safer C-Sections

A new FDA-registered medical device promising to eliminate fetal lacerations during Caesarean sections is gaining popularity.  Doctors are offering an alternative to the traditional scalpel, called the C SAFE, as C-sections approach a 33 percent national rate, increasing the risk of injury to newborns.

Obamacare’s tax on innovation

Physician-inventor Robert E. Fischell says taxing medical devices will hurt industry’s ability to develop products

Soldier injured in bomb blast gets rare double arm transplant

BALTIMORE — Perched on a therapy table at Johns Hopkins Hospital, one of the few quadruple amputees from the Iraq War reached up over his head with both hands and launched a pink ball to the Marine Corps commandant.  Five months ago, Army Sgt. Brendan Marrocco’s arms belonged to someone else.