Lori A Carr An international study involving 255 physicians practicing in Vancouver, Montreal, Sacramento and Toulouse found that physicians are not given enough information about the adverse effects of drugs during presentations made by medical sales representatives from pharmaceutical companies. And yet, these same physicians are willing to prescribe at least some of the presented drugs.
On May 23, the U.S. Food and Drug Administration announced that it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals. This is the first HbA1c test that FDA has allowed to be marketed for this use. The HbA1c tests, or A1c tests, currently on the market are FDA-cleared for monitoring a patient’s blood glucose (sugar) control, but not for diagnosing diabetes. A1c tests measure the percentage of hemoglobin A1c that is bound to glucose, giving a patient’s average glucose level over a three-month period.
The FDA lowers the regulatory bar for ingestible event markers, downgrading them from Class II to Class III devices. Effective May 17, the FDA is down-classifying ingestible event markers from the more burdensome Class III into Class II (special controls).
The Food and Drug Administration is able to do its work in part because of a symbiotic relationship with the industries it regulates. But recently that relationship has been knocked off balance.
Lori, Caleb Nolan would probably object to be called little. He’s an active 7-year-old who plays football, baseball, soccer and basketball. He also was born with a rare form of cystic fibrosis that requires him to undergo rigorous treatments and take 23 pills every day.
Across 66 Countries, Data Reveals Technology-Focused Healthcare Cost-Containment Policies are Misguided; A new study of medical device spending in 66 countries finds that medical devices are a smaller burden on health spending, and are more affordable relative to GDP in Canada compared to most other countries
The US Food and Drug Administration (FDA) may still be in the midst of figuring out how to overhaul its medical device compliance approach in regards to quality, but a new report out from device consultancy Emergo Group shows that the agency is dramatically ramping up the number of quality-related deficiencies it cites in its inspection reports.
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.
AdvaMed; November 13 – 14, 2013 — Sheraton Crystal City, Arlington, VA
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.