Advertising and Promotion of Medical Devices
AdvaMed; November 13 – 14, 2013 — Sheraton Crystal City, Arlington, VA
Uncategorized
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.
Researchers seek FDA approval for diabetes cell transplants
Cell transplants could cure many of diabetes.
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
Study: Women and Non-White Patients More Likely to be Non-Adherent to Medications
CVS Caremark Research Finds Women and Non-White Patients More Likely to be Non-Adherent to Medications. Non-white patients have 50 percent greater odds, women have 10 percent greater odds of being non-adherent to statin medications for treatment of high cholesterol.
FDA working to improve device-review process
FDA med device chief pledges ‘no more Columbo moments’
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.
More device giants acquire Chinese companies, report
Growth in the global medical device market might be stymied by health care reform in the U.S. and economic challenges in Europe, but a new report finds that another trend has been emerging: the acquisition of small Chinese companies by large U.S. medical device manufacturers.
FDA Wants Input on Quality Inspection, Import Procedures Under FDASIA
When US legislators and President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in July 2012, they did so – among other reasons – in the hope that provisions within the bill would help protect the supply chain for pharmaceutical products, which are increasingly being made and manufactured outside US shores. Now the US Food and Drug Administration (FDA) is looking to actualize those hopes, announcing a public meeting and a call for comments on how it can best implement FDASIA’s supply chain security provisions.