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FDA med device chief pledges ‘no more Columbo moments’

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.

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.

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.

The role of pharma sales reps has changed in recent years, however, physicians still view reps as the leading influence on their relationships with biopharma companies, according to the recently released J.D. Power and Associates 2013 Physician Manufacturer Experience Study—Oncology.  The study is the first in a series that will examine physician satisfaction with biopharmaceutical manufacturers.  The oncology study looks at oncologist and hematologist satisfaction based on the following factors: sales representative interactions; contributions to advancing medical care; medical marketing practices; patient education programs and materials; and service process.

The Food and Drug Administration, acting on a law signed by President Obama in 2012, has launched the third phase of an initiative to increase patient participation in the regulation of drugs and medical devices. On a Wednesday in April, the agency went live with a new website aimed at demystifying the regulatory process for consumers and patient advocates.

NEW YORK (Reuters) – As the clock ticks down to the start of a U.S. healthcare overhaul, companies from device makers to hospital chains have been surprised to see Americans make even fewer trips to the doctor’s office.

The US Food and Drug Administration (FDA) has released two long-awaited guidance documents regarding the appeals process to be used by medical device manufacturers that have received a rejection by the agency.

The US Food and Drug Administration has published a report updating its plans for a nationwide medical device post-market surveillance system, including implementation of a Unique Device Identification (UDI) framework.

The refurbished medical equipment market is slated to be worth $9 billion by 2018, building at an annual growth rate of 8.2 percent, according to a new report from Transparency Market Research.